A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
GlaxoSmithKline
Study ID
NCT07645235
Phase
PHASE1
Status
Recruiting
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Conditions

  • Urinary Tract Infections

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Gepotidacin — DRUG
    A single oral dose of 3000 mg gepotidacin will be administered

Study Details

This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.

Key Dates

First listed
Jun 12, 2026
Start date
Jul 23, 2026
Status verified
Sep 2026
Primary completion
May 17, 2027
Completion
May 17, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving Gepotidacin

Primary Outcome Measure

Area under the concentration-time curve from time zero to the last measurable concentration time point (t) (AUC[0 to t]) of gepotidacin in breast milk [ Time Frame: Up to 48 hours post dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLas VegasNevada89113-2235
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Darin Brimhall (PRINCIPAL_INVESTIGATOR)

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By research site
GSK Investigational Site· Las Vegas, NV

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