Urinary Tract InfectionsPhase 1NCT07645235
A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
A Phase 1 study testing Gepotidacin in people with Urinary Tract Infections, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Gepotidacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2026to 17 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Las Vegas, Nevada, 89113-2235
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Gepotidacin in Healthy Lactating Women
This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.
- Conditions
- Urinary Tract Infections
- Being tested
- Gepotidacin
- Keywords
- Gepotidacin, Pharmacokinetics, Healthy Lactating Women
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GepotidacinDrug
A single oral dose of 3000 mg gepotidacin will be administered
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Gepotidacin | Experimental | Not described Receives: Drug: Gepotidacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 48 hours post dose
Secondary outcomes (11)
AUC(0 to t) of gepotidacin in plasma
Measured: Up to 48 hours post dose
Maximum drug concentration (Cmax) of gepotidacin in plasma
Measured: 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
Measured: Up to 48 hours post dose
AUC(0 to infinity) of gepotidacin in breast milk
Measured: Up to 48 hours post dose
Cmax of gepotidacin in breast milk
Measured: Up to 48 hours post dose
Concentration of gepotidacin in breast milk from time zero to the last measurable concentration time point (0 to t)
Measured: Up to 48 hours post dose
Fraction of gepotidacin excreted in breast milk (0 to t) after a single dose administration
Measured: Up to 48 hours post dose
Breast milk to Plasma ratio for AUC (0 to t) of gepotidacin
Measured: Up to 48 hours post dose
Breast milk to Plasma ratio for AUC (0 to infinity) of gepotidacin
Measured: Up to 48 hours post dose
Breast milk to Plasma ratio for Cmax of gepotidacin
Measured: Up to 48 hours post dose
Number of participants with adverse events (AEs) and serious adverse event (SAEs)
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start23 Jul 2026
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645235
- Sponsor's protocol ID
- 300585
- Other IDs
- HSSO100201300011C
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Gepotidacin in Healthy Lactating Women
- ClinicalTrials.gov ID
- NCT07645235
- Acronym / sponsor ID
- 300585
- Conditions
- Urinary Tract Infections
- Keywords
- Gepotidacin, Pharmacokinetics, Healthy Lactating Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Gepotidacin | Experimental | Drug: Gepotidacin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GepotidacinA single oral dose of 3000 mg gepotidacin will be administered | Drug | Participants receiving Gepotidacin |
Primary outcome
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
11 secondary outcomes
AUC(0 to t) of gepotidacin in plasma
Time frame: Up to 48 hours post dose
Maximum drug concentration (Cmax) of gepotidacin in plasma
Time frame: 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
Time frame: Up to 48 hours post dose
AUC(0 to infinity) of gepotidacin in breast milk
Time frame: Up to 48 hours post dose
Cmax of gepotidacin in breast milk
Time frame: Up to 48 hours post dose
Concentration of gepotidacin in breast milk from time zero to the last measurable concentration time point (0 to t)
Time frame: Up to 48 hours post dose
Fraction of gepotidacin excreted in breast milk (0 to t) after a single dose administration
Time frame: Up to 48 hours post dose
Breast milk to Plasma ratio for AUC (0 to t) of gepotidacin
Time frame: Up to 48 hours post dose
Breast milk to Plasma ratio for AUC (0 to infinity) of gepotidacin
Time frame: Up to 48 hours post dose
Breast milk to Plasma ratio for Cmax of gepotidacin
Time frame: Up to 48 hours post dose
Number of participants with adverse events (AEs) and serious adverse event (SAEs)
Time frame: Up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gepotidacin in people with Urinary Tract Infections, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.