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Tebipenem pivoxil hydrobromide

Phase 1

Renal Impairment | Small molecule | Nephrology |Spero Therapeutics, Inc.|Last Updated: Nov 27, 2020

Success Probability
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical trial landscape

Tebipenem pivoxil hydrobromide · 2 trials · 2 indications

Phase 1 2
NCT04368585Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult SubjectsHealthy Volunteers
COMPLETED20 Analytics
NCT04178577Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal FunctionRenal Impairment
COMPLETED39 Analytics
PHASE1COMPLETED
Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Healthy Volunteers
NCT0436858520
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PHASE1COMPLETED
Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function
Renal Impairment
NCT0417857739
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Study Endpoints
Primary Endpoints
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t).
Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Area under the curve extrapolated to infinity (AUC0-∞).
Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Percent of AUC0-inf extrapolated (AUC%extrap)
Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Maximum plasma concentration (Cmax).
Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Time to the maximum plasma concentration (Tmax).
Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Terminal elimination half-life (t½).
Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Apparent total body clearance (CL/F)
Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Apparent total body clearance (CL/F).
72 hours post dose
Area under the curve from time zero to the last quantifiable sample (AUC0-last).
72 hours post dose
Apparent steadystate volume of distribution (Vss/F).
72 hours post dose
Terminal elimination half-life (t1/2).
72 hours post dose
Secondary Endpoints
Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.
12 to 14 days after the last dose of study drug
Significant changes from baseline in clinical laboratory values.
14 days post last dose
Significant changes from baseline in physical examination.
14 days post last dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
TBPM-PI-HBr Alone (Period 1)EXPERIMENTALTebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally alone.
TBPM-PI-HBr and Antacid (Period 2)EXPERIMENTAL20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension will be coadministered with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr at Hour 0 on Day 1.
TBPM-PI-HBr and Omeprazole (Period 3)EXPERIMENTAL40 mg (1 x 40 mg capsule) omeprazole administered QD at Hour -2 on Days 1 through 5, with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr administered at Hour 0 on Day 5.
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)EXPERIMENTALTebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
Interventions
NameTypeDescription
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)DRUGTebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL)DRUG20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension.
OmeprazoleDRUG40 mg (1 x 40 mg capsule) omeprazole administered QD
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Eligibility Criteria
Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit. * Continuous non-smoker * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit. * Medically healthy with no clinically significant medical history, physical examination, ...

Countries:United States
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