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

An Open-Label, 3-Period, Fixed-Sequence, Study to Examine the Effect of Aluminum Hydroxide/Magnesium Hydroxide/Simethicone and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-08-08
• Completion: 2020-08-21
• First posted: 2020-04-30
• Last updated: 2020-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study