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NCT07645235 · GlaxoSmithKline

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

What this study is about

This study aims to evaluate the how the drug moves through the body of gepotidacin in fed healthy lactating women.

View original scientific description

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

Interventions

DRUG

Gepotidacin

A single oral dose of 3000 mg gepotidacin will be administered

Primary outcome measures

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

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.
  • Having two or more of the following risk factors: 1. Body weight between 45 kg and 60 kg, 2. Moderate renal impairment (creatinine clearance 30 to 59 mL/min), 3. Moderate hepatic impairment (Child Pugh Class B)
  • QTc \>450 milliseconds (msec) or QTc \>480 msec for participants with bundle branch block.
  • Severe hepatic impairment (Child Pugh Class C)
  • Alanine aminotransferase \>1.5\*upper limit of normal (ULN).
  • Total bilirubin \>1.5\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5\*ULN if direct bilirubin is \<=1.5\*ULN.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).

Where

  • Las Vegas, Nevada

Collaborators

Biomedical Advanced Research and Development Authority

Related conditions & keywords

Urinary Tract InfectionsGepotidacinPharmacokineticsHealthy Lactating Women

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Sep 30, 2026 · Source of record for eligibility and locations

📊
1 of 8 participants interested
13% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Las Vegas

Nevada

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Urinary Tract Infections Treatment in Las Vegas?

Join others in Nevada exploring innovative treatment options through clinical research

Urinary Tract Infections Treatment Options in Las Vegas, Nevada

If you're searching for Urinary Tract Infections treatment in Las Vegas, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Las Vegas and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Urinary Tract Infections. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Nevada
Now Enrolling
Up to 8 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Urinary Tract Infections?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Urinary Tract Infections

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Urinary Tract Infections Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07645235. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.