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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving Gepotidacin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gepotidacin | Drug | A single oral dose of 3000 mg gepotidacin will be administered |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Healthy lactating women will be enrolled in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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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
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.
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.
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000612856 | gepotidacin |
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This is an open label study
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| 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 |
| Concentration of gepotidacin in breast milk from time zero to the last measurable concentration time point (0 to t) | Up to 48 hours post dose |
| Fraction of gepotidacin excreted in breast milk (0 to t) after a single dose administration | Up to 48 hours post dose |
| Breast milk to Plasma ratio for AUC (0 to t) of gepotidacin | Up to 48 hours post dose |
| Breast milk to Plasma ratio for AUC (0 to infinity) of gepotidacin | Up to 48 hours post dose |
| Breast milk to Plasma ratio for Cmax of gepotidacin | Up to 48 hours post dose |
| Number of participants with adverse events (AEs) and serious adverse event (SAEs) | Up to 14 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |