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Drug-drug Interaction Study of Gepotidacin

NCT04493931 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-03-04

Study results available
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Summary

This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.

Conditions

  • Infections, Bacterial

Interventions

DRUG

Gepotidacin

Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.

DRUG

Cimetidine

Cimetidine tablets will be available as unit dose strength 400 mg and will be administered orally.

DRUG

Rifampicin

Rifampicin Capsules will be available as unit dose strength 300 mg and will be administered orally.

DRUG

Midazolam

Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.

DRUG

Digoxin

Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.

OTHER

Placebo matching to gepotidacin

Placebo matching to gepotidacin tablets will be administered orally.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-08-14
Primary Completion
2020-12-21
Completion
2020-12-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04493931 on ClinicalTrials.gov