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RO7079901

Phase 1

Healthy Volunteers | Small molecule | Other |Roche Holding AG|Last Updated: May 15, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

RO7079901 · 3 trials · 3 indications

Phase 1 3
NCT03174795A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract InfectionUrinary Tract Infections
COMPLETED20 Analytics
NCT02975388A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901Renal Impairment
COMPLETED29 Analytics
NCT02972255A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7079901 and the Combination of RO7079901 With Meropenem in Adult Healthy VolunteersHealthy Volunteers
COMPLETED46 Analytics
PHASE1COMPLETED
A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection
Urinary Tract Infections
NCT0317479520
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PHASE1COMPLETED
A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901
Renal Impairment
NCT0297538829
Unlock trial analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7079901 and the Combination of RO7079901 With Meropenem in Adult Healthy Volunteers
Healthy Volunteers
NCT0297225546
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Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUC0-tau) of RO7079901
Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Total Clearance (CL) of RO7079901
Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Renal Clearance (CLr) of RO7079901
Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Maximum Observed Plasma Concentration (Cmax) of RO7079901
Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Cumulative Amount Excreted in Urine Over the Dosing Interval (Ae) of RO7079901
Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Fraction Excreted into the Urine (Fe) of RO7079901
Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Time of Maximum Observed Plasma Concentration (Tmax) of RO7079901
Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Steady State Volume of Distribution (Vss) of RO7079901
Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Total Body Clearance (CL) of RO7079901 Using Plasma Concentration Data
Blood: Part 1 - Predose (-1 to 0 hour [hr]), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
Volume of Distribution of the Central Compartment (Vc) of RO7079901 Using Plasma Concentration Data
Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
Total Volume of Distribution (Vz) of RO7079901 Using Plasma Concentration Data
Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
Volume of Distribution at Steady-State (Vss) of RO7079901 Using Plasma Concentration Data
Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)
Part 2: Dialysis Clearance (CLd) of RO7079901
Dialyzer input, output blood and dialyzer fluid: 1.5 hours postdose (start of hemodialysis); 2.5, 3.5, 4.5 hours postdose (end of hemodialysis) (infusion length: 0.5 hr)
Measured Creatinine Clearance (mCLcr)
Blood and Urine: Day -1 ( over the 24-hr period predose corresponding to time of micturition), Day 1 ( Part 1)
Estimated Creatinine Clearance Using the Cockcroft and Gault Formula (eCLcr[CG])
Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
Estimated Creatinine Clearance Using the Modified Jelliffe Formula (eCLcr[Jelliffe])
Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
Estimated Glomerular Filtration Rate (eGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (eGFR[MDRD])
Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
eGFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Formula (eGFR[CKD-EPI])
Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)
Part I: Percentage of Participants With Adverse Events
From screening to the follow-up or early withdrawal visit (up to Day 15)
Part II: Percentage of Participants With Adverse Events
From screening to the follow-up or early withdrawal visit (up to Day 17)
Part III: Percentage of Participants With Adverse Events
From screening to the follow-up or early withdrawal visit (up to Day 17)
Part I: Maximum Observed Plasma Concentration (Cmax) of RO7079901
Pre-infusion (0-1 hour [hr]) (infusion duration: 90 minutes [min]), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Time to Reach Cmax (Tmax) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Area Under the Plasma Concentration-Time Curve From Time Zero Until End of Dosing Interval (AUC0-tau) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Terminal Elimination Rate Constant of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Terminal Elimination Half-Life (t1/2) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Total Clearance (CL) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Volume of Distribution at Steady State (Vss) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Cmax of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Tmax of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: AUC0-tau of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Terminal Elimination Rate Constant of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: t1/2 of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Cmax of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Tmax of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: AUC0-tau of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: Terminal Elimination Rate Constant of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part I: t1/2 of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 1; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Day 7
Part II - Single Dose: Cmax of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Tmax of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-tau of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Terminal Elimination Rate Constant of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: t1/2 of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: CL of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Vss of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Cmax of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Tmax of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-tau of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Terminal Elimination Rate Constant of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: t1/2 of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Cmax of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Tmax of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-tau of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Terminal Elimination Rate Constant of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: t1/2 of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Repeat Dose: Cmax of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Tmax of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: AUC0-tau of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Terminal Elimination Rate Constant of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: t1/2 of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: CL of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Vss of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Cmax of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Tmax of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: AUC0-tau of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Terminal Elimination Rate Constant of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: t1/2 of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Cmax of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Tmax of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: AUC0-tau of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: Terminal Elimination Rate Constant of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part II - Repeat Dose: t1/2 of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Days 1 and 9
Part I: Cumulative Amount of RO7079901 Excreted in Urine (Ae)
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Ae From Time 0 to End of the Dosing Interval (8 hrs) (Ae0-tau) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Percent of RO7079901 Dose Excreted in Urine (Ae%), Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Renal Clearance (CLr) of RO7079901, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Ae of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Ae0-tau of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Ae of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Ae0-tau of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part I: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8 hrs post-infusion start on Day 1; pre-infusion (0-1 hr), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 7
Part II - Single Dose: Ae of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: Ae0-tau of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: Ae% of RO7079901, Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: Ae of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: Ae0-tau of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: Ae of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: Ae0-tau of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Single Dose: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II - Repeat Dose: Ae of RO7079901
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: Ae0-tau of RO7079901
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: Ae% of RO7079901, Calculated as Ae0-tau/Dose
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: Ae of Metabolite RO7110880
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: Ae0-tau of Metabolite RO7110880
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: Ae of Metabolite RO7053802
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: Ae0-tau of Metabolite RO7053802
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Repeat Dose: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau
Pre- infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 and 9
Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-last of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-24h of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-inf of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-last of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-24h of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Single Dose: AUC0-inf of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hrs post infusion on Day 1
Part II - Repeat Dose: AUC0-last of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II - Repeat Dose: AUC0-24h of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II - Repeat Dose: AUC0-inf of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II - Repeat Dose: AUC0-last of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II - Repeat Dose: AUC0-24h of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II - Repeat Dose: AUC0-inf of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II - Repeat Dose: AUC0-last of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II - Repeat Dose: AUC0-24h of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II - Repeat Dose: AUC0-inf of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post infusion on Day 1; pre-infusion (0-1 hr) on Day 2
Part II: Cumulative Amount of RO7079901 Excreted in Urine From Time 0 to 24 Hours (Ae0-24h)
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II: Ae% of RO7079901, Calculated as Ae0-24h/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II: CLr of RO7079901, Calculated as Ae0-24h/AUC0-24h
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II: Ae0-24 of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II: Ae% of Metabolite RO7110880, Calculated as Ae0-24h/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II: CLr of Metabolite RO7110880, Calculated as Ae0-24h/AUC0-24h
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II: Ae0-24 of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II: Ae% of Metabolite RO7053802, Calculated as Ae0-24h/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part II: CLr of Metabolite RO7053802, Calculated as Ae0-24h/AUC0-24h
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Day 1
Part III: Cmax of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: Tmax of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: AUC0-tau of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: AUC0-last of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
Part III: AUC0-inf of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
Part III: Terminal Elimination Rate Constant of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: t1/2 of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: CL of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: Vss of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: Cmax of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: Tmax of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: AUC0-tau of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: AUC0-last of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
Part III: AUC0-inf of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
Part III: Terminal Elimination Rate Constant of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: t1/2 of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: Cmax of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: Tmax of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: AUC0-tau of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: AUC0-last of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
Part III: AUC0-inf of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence)
Part III: Terminal Elimination Rate Constant of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: t1/2 of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post-infusion on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-infusion on Day 3
Part III: Ae of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae0-tau of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae0-24h of RO7079901
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
Part III: Ae% of RO7079901, Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae% of RO7079901, Calculated as Ae0-24h/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
Part III: CLr of RO7079901, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: CLr of RO7079901, Calculated as Ae0-24h/AUC0-24h
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
Part III: Ae of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae0-tau of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae0-24h of Metabolite RO7110880
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
Part III: Ae% of Metabolite RO7110880, Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae% of Metabolite RO7110880, Calculated as Ae0-24h/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
Part III: CLr of Metabolite RO7110880, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: CLr of Metabolite RO7110880, Calculated as Ae0-24h/AUC0-24h
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
Part III: Ae of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae0-tau of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae0-24h of Metabolite RO7053802
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
Part III: Ae% of Metabolite RO7053802, Calculated as Ae0-tau/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: Ae% of Metabolite RO7053802, Calculated as Ae0-24h/Dose
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)
Part III: CLr of Metabolite RO7053802, Calculated as Ae0-tau/AUC0-tau
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence) and 9; pre-infusion (0-1 hr), and 0-4, 4-8 hrs post-infusion start on Day 3
Part III: CLr of Metabolite RO7053802, Calculated as Ae0-24h/AUC0-24h
Pre-infusion (0-1 hr) (infusion duration: 90 min), and 0-4, 4-8, 8-12, 12-24 hrs post-infusion start on Days 1 or 2 (depending on treatment sequence)

Secondary Endpoints

AUC0-tau of Meropenem
Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
CL of Meropenem
Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
CLr of Meropenem
Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7079901 and MeropenemEXPERIMENTALParticipants will receive RO7079901 and meropenem. The duration of study drug treatment will be determined by the investigator after evaluation of the participant's response to study drug treatment. Participants should receive a minimum treatment period of 3 days and up to 14 days of intravenous (IV) study drug treatment.
Label: RO7079901 (Mild) (Part 1)EXPERIMENTALParticipants with mild renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
RO7079901 (Moderate) (Part 1)EXPERIMENTALParticipants with moderate renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
RO7079901 (Severe) (Part 1)EXPERIMENTALParticipants with severe renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
RO7079901 (Normal) (Part 1)ACTIVE_COMPARATORControl group of participants with normal renal function will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
RO7079901 (End-stage) (Part 2)EXPERIMENTALParticipants with stable end-stage renal disease undergoing hemodialysis will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
Part I: RO7079901EXPERIMENTALParticipants will be randomized in two dose cohorts to receive single dose of RO7079901 1000 and 2000 milligrams (mg) intravenous (IV) infusion on Days 1 through Day 7 every 8 hours (q8h), for a total of 19 doses, with the last dose administered on the morning of Day 7.
Part I: PlaceboPLACEBO_COMPARATORParticipants will be randomized in two dose cohorts to receive single dose of placebo matching to RO7079901 on Days 1 through Day 7 q8h, for a total of 19 doses, with the last dose administered on the morning of Day 7.
Part II - Single Dose and Repeat Dose: RO7079901EXPERIMENTALParticipants will be randomized in two dose cohorts to receive single dose of RO7079901 IV infusion at a dose above the previously studied dose levels in Part I (greater than \[\>\] 2000 mg) on Day 1, with the option to extend to q8h dosing for 7 days (i.e., starting on Day 3 through Day 9); once PK, safety and tolerability have been confirmed up to 48 hrs after the single dose.
Part II - Single Dose and Repeat Dose: PlaceboPLACEBO_COMPARATORParticipants will be randomized in two dose cohorts to receive single dose placebo matching to RO7079901 on Day 1, with the option to extend to q8h dosing for 7 days (i.e., starting on Day 3 through Day 9); once PK, safety and tolerability have been confirmed up to 48 hrs after the single dose.
Part III: RO7079901 + MeropenemEXPERIMENTALParticipants will be randomized in three dose cohorts to receive RO7079901 and Meropenem IV infusion in one of the 2 treatment sequences. Participants randomized to Sequence 1 will receive a single dose of 2000 mg meropenem IV infusion on Day 1. On Day 2, participants will receive a single dose of RO7079901 IV infusion. Participants randomized to Sequence 2 will receive a single dose of RO7079901 IV infusion on Day 1. On Day 2, participants will receive a single dose of 2000 mg meropenem IV infusion. Starting on Day 3 and continuing through Day 9 (i.e., for a total of 19 doses, last dose in the morning of Day 9) all participants will receive RO7079901 in combination with meropenem IV infusion q8h, regardless of sequence. Escalation to a maximum dose of RO7079901 5000 mg q8h may be considered on the basis of safety and tolerability data from the previous cohorts.
Part III: RO7079901 Placebo + Meropenem PlaceboPLACEBO_COMPARATORParticipants will be randomized in three dose cohorts to receive RO7079901 and Meropenem matching placebos in one of the 2 treatment sequences. Participants randomized to Sequence 1 will receive a single dose of placebo matching to meropenem on Day 1. On Day 2, participants will receive a single dose of placebo matching to RO7079901. Participants randomized to Sequence 2 will receive a single dose of placebo matching to RO7079901 on Day 1. On Day 2, participants will receive a single dose of placebo matching to meropenem. Starting on Day 3 and continuing through Day 9 (i.e., for a total of 19 doses, last dose in the morning of Day 9) all participants will receive RO7079901 and meropenem matching placebos q8h, regardless of sequence.

Interventions

NameTypeDescription
RO7079901DRUGParticipants will receive RO7079901 2000 milligrams (mg) IV treatment, three times a day (TID) for up to 14 days.
MeropenemDRUGParticipants will receive meropenem 2000 mg IV treatment TID for up to 14 days.
RO7049389 PlaceboOTHERPlacebo matching to RO7049389 will be administered as per schedule described in individual arm.
Meropenem PlaceboOTHERPlacebo matching to meropenem will be administered as per schedule described in individual arm.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis) * Clinical signs and/or symptoms of pyelonephritis or a cUTI * Urine culture taken within the 48 hours (hr) period immediately preceding the first dos...

Countries:United StatesHungaryLatviaPolandSerbia
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Frequently asked questions about RO7079901

What is RO7079901 used for?

RO7079901 is an investigational small molecule being studied for use in healthy volunteers, urinary tract infections, and renal impairment. It has been evaluated in Phase 1 clinical trials, including studies in patients with complicated urinary tract infections and in individuals with varying degrees of renal function.

Who makes RO7079901?

RO7079901 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored Phase 1 clinical trials to investigate the safety, tolerability, and pharmacokinetics of the drug.

What phase is RO7079901 in?

RO7079901 is in Phase 1 clinical development. All three completed trials for the drug are Phase 1 studies, meaning it is still in early-stage clinical testing and is not yet approved for any use.

What clinical trials is RO7079901 in?

RO7079901 has been studied in three completed Phase 1 trials: NCT02972255, which examined safety and pharmacokinetics in healthy volunteers; NCT02975388, which assessed the effect of renal function and hemodialysis on the drug's pharmacokinetics; and NCT03174795, which investigated the drug with meropenem in complicated urinary tract infections.

Is RO7079901 FDA approved?

RO7079901 is not FDA approved. It is an investigational drug that has only been tested in Phase 1 clinical trials, which are designed to assess safety, tolerability, and pharmacokinetics in small numbers of participants. Further clinical development would be needed before any approval could be considered.