Health TrialsbyHealthPanel

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

ConditionUrinary Tract Infections
Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Gepotidacin

    Drug

    A single oral dose of 3000 mg gepotidacin will be administered

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: Participants receiving GepotidacinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

AUC(0 to t) of gepotidacin in plasma

Time frame
Up to 48 hours post dose
2

Maximum drug concentration (Cmax) of gepotidacin in plasma

Time frame
Up to 48 hours post dose
3

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
4

AUC(0 to infinity) of gepotidacin in breast milk

Time frame
Up to 48 hours post dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator

Source ClinicalTrials.gov
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