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

NCT07645235 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 300585
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Urinary Tract Infections

Keywords

Gepotidacin; Pharmacokinetics; Healthy Lactating Women

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 48 hours post dose

Secondary Outcomes (11)

• AUC(0 to t) of gepotidacin in plasma

  Up to 48 hours post dose

• Maximum drug concentration (Cmax) of gepotidacin in plasma

  Up to 48 hours post dose

• Area under the concentration-time curve from time zero to infinity (AUC[0 to infinity]) of gepotidacin in plasma

  Up to 48 hours post dose

• AUC(0 to infinity) of gepotidacin in breast milk

  Up to 48 hours post dose

• Cmax of gepotidacin in breast milk

  Up to 48 hours post dose

Study Arms (1)

Participants receiving Gepotidacin

EXPERIMENTAL

Drug: Gepotidacin

Interventions

Gepotidacin DRUG

A single oral dose of 3000 mg gepotidacin will be administered

Participants receiving Gepotidacin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Healthy lactating women will be enrolled in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be healthy lactating women, 18 to 50 years of age, inclusive, at Screening.
• Actively breastfeeding or expressing breast milk.
• At least 28 days postpartum with a full milk supply established, and with no persistent complications from delivery (there is no maximal length of time postpartum required).
• Willingness to temporarily discontinue feeding breast milk to infants from dosing through to 72 hours after dosing (approximately 3 days), with the ability to pump and provide reserve milk for bottle feeding prior to the study OR has decided to permanently discontinue breastfeeding but has not started weaning, provided the infant accepts bottle feeding and a sufficient milk supply is maintained by pumping 3 to 4 times daily, considering changes in milk composition during weaning process.
• Is willing to fully express breast milk from both breasts during the duration of the milk collection portion of the study. Participants must be able to express milk from each breast at each pumping session using a breast pump.
• Has a body mass index (BMI) of less than or equal to (\<=) 36 kilograms per meter square (kg/m\^2) and weighs at least 45 kilograms (kg) with all clinical assessments considered as clinically non-significant per investigator.
• Non-smoker (including vaping) or prior smokers (having smoked less than 10 cigarettes per day) who have stopped smoking for at least 1 month prior to screening.
• Understands the study procedures and is capable of providing written informed consent.
• 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.

You may not qualify if:

• Participant is unwilling or unable to comply with the study restrictions or lifestyle guidelines presented in the protocol during the study period and through the post study visit.
• History or evidence of any clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric (including post-natal depression), neurologic, infectious, neoplastic, active cancer or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing) or clinical findings that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant or infant by participation in the study.
• Has had major surgery in the past 3 months (except delivery through a C section and/or tubal ligation).
• History of significant multiple and/or severe allergies (including latex allergy, but with exception of seasonal rhinitis \[hay fever\]) or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
• Hypersensitivity to gepotidacin.
• Current or recent (less than \[\<\] 14 days) mastitis, or history of breast surgery (augmentation or reduction).
• Use of any QT prolonging medications within 7 days prior to first dose, use of strong or moderate Cytochrome P450 3A4 (CYP3A4) inhibitors within 7 days prior to first dose, or use of strong or moderate CYP3A4 inducers (including vitamins, herbal and dietary supplements such as St. John's wort) within 14 days prior to first dose.
• Currently a user of illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year.
• Donated or lost 1 unit of blood (approximately 500 milliliters \[mL\]) or participated in another investigational study within 30 days or 5 half-lives of the investigational product prior to the screening. The 30 days window will be derived from the date of the last study procedure (i.e., poststudy, AE follow-up, etc.) in the previous study to the screening visit of the current study.
• The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
• Participants with excessive caffeine intake (defined as greater than \[\>\] 6 servings \[1 serving is approximately equivalent to 120 milligram \[mg\] of caffeine\] of coffee, tea, cola or other caffeinated beverages per day) within 14 days prior to first dose.
• The participant has known severe renal impairment (creatinine clearance \<30 milliliters per minute \[mL/min\] or clinically significant elevated serum creatinine as determined by the investigator).
• The participant presents with (self-reported) vaginal discharge suspected for infection at Baseline.
• The participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval.
• The participant has a family history of QT prolongation or sudden death.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Biomedical Advanced Research and Development Authority: collaborator

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

gepotidacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 9, 2026
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 13, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.