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8 Participants NeededMy employer runs this trial

Gepotidacin Exposure in Breast Milk

Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: GlaxoSmithKline
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for healthy breastfeeding women aged 18-50 who are at least 28 days postpartum, have a full milk supply, and can temporarily stop feeding breast milk to their infants for about 3 days. Participants must be non-smokers or former light smokers and meet certain health requirements.

Inclusion Criteria

* A negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) will be required at Baseline before the dose of study intervention.
I am willing to stop breastfeeding for 3 days after treatment or have chosen to stop breastfeeding.
I am a healthy breastfeeding woman between 18 and 50 years old.
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What Are the Treatments Tested in This Trial?

Interventions

  • Gepotidacin

Trial Overview

The study tests how much of the antibiotic gepotidacin passes into breast milk after a single dose in healthy lactating women. Participants will provide multiple breast milk samples over several days.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants receiving GepotidacinExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Biomedical Advanced Research and Development Authority

Collaborator

Trials
108
Recruited
574,000+

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