A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
NCT07645235 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-06-12
Summary
This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.
Conditions
Interventions
- DRUG
-
Gepotidacin
A single oral dose of 3000 mg gepotidacin will be administered
Sponsors & Collaborators
-
Biomedical Advanced Research and Development Authority
collaborator FED - lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-09
- Primary Completion
- 2027-05-05
- Completion
- 2027-05-13
- FDA Drug
- Yes
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