A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
ConditionUrinary Tract Infections
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorGlaxoSmithKline
About this trial
This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gepotidacin
Treatment groups
8 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
GlaxoSmithKline
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
Source ClinicalTrials.gov