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RO7079901

Phase 1

Renal Impairment | Small molecule | Nephrology |Roche Holding AG|Trials Updated: May 15, 2018

RO7079901 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Nov 2016

RO7079901 target and mechanism

ModalitySmall molecule

Also known as nacubactam

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials3
Total Enrollment70

FDA Designations

No designations recorded

RO7079901 clinical trials

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
NCT03182504A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy ParticipantsGram-negative Bacterial Infections
COMPLETED21 Analytics
NCT02975388A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901Renal Impairment
COMPLETED29 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 Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
Gram-negative Bacterial Infections
NCT0318250421
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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
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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
Epithelial Lining Fluid (ELF) Concentration of Nacubactam to Plasma Concentration of Nacubactam Ratio
At 2, 3, 4, 6 and 8 hours after study drug administration

The ELF to plasma ratio will be calculated from the concentration of nacubactam in ELF and plasma as a measure of the intrapulmonary penetration of nacubactam in healthy participants.

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)

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)
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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.
Nacubactam Plus MeropenemEXPERIMENTALParticipants will receive a single dose of nacubactam co-administered with meropenem.
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.

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.
nacubactamDRUGParticipants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours.
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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 urinary tract infections and for use in people with renal impairment. It has been evaluated in Phase 1 clinical trials, including a study in participants with complicated urinary tract infection and a study examining how kidney function and hemodialysis affect the drug's pharmacokinetics.

Who is developing RO7079901?

RO7079901 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical studies conducted for this asset.

What phase is RO7079901 in?

RO7079901 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The completed Phase 1 trials evaluated its pharmacokinetics in complicated urinary tract infection and in participants with varying renal function, including those on hemodialysis.

What clinical trials is RO7079901 in?

RO7079901 has been studied in two completed Phase 1 trials. NCT03174795 investigated the pharmacokinetics of RO7079901 and meropenem in participants with complicated urinary tract infection across the United States, Hungary, Latvia, Poland, and Serbia. NCT02975388 examined the effect of renal function and hemodialysis on RO7079901 pharmacokinetics in the United States.

How many patients were enrolled in RO7079901 trials?

The RO7079901 clinical program enrolled a total of 29 participants across its trials. The complicated urinary tract infection study, NCT03174795, enrolled 20 participants, while the renal impairment pharmacokinetics study, NCT02975388, enrolled 29 participants, including healthy volunteers.

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