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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

NCT04368585 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • David Melnick, M.D. · Spero Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-08-08
Completion
2020-08-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368585 on ClinicalTrials.gov