NCT04368585View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

August 8, 2020

Study Completion Date

August 21, 2020

Conditions
Healthy Volunteers
Interventions
DRUG

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.

DRUG

20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL)

20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension.

DRUG

Omeprazole

40 mg (1 x 40 mg capsule) omeprazole administered QD

Trial Locations (1)

85283

Medical Facility, Phoenix

Sponsors

Lead Sponsor

Spero Therapeutics
All Listed Sponsors
lead

Spero Therapeutics

INDUSTRY

NCT04368585 - 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 | Biotech Hunter | Biotech Hunter