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NCT07645235
A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
Conditions: Urinary Tract Infections
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 8
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site Las Vegas Nevada
Summary
This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.
Eligibility Criteria
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 (\1.5\*ULN if direct bilirubin is \
Source: ClinicalTrials.gov (NCT07645235). StuddyBuddy aggregates publicly available trial information.