An Open-label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of Zoliflodacin 3 g in Milk and Plasma in Healthy Lactating Women

Summary

This is a single-arm clinical trial to evaluate the PK profile in breast milk and plasma after a single oral dose of zoliflodacin in healthy lactating women. Eligible participants who have been actively breastfeeding or expressing milk for at least 4 weeks postpartum will receive a single dose of zoliflodacin administered as an oral suspension with food. Breast milk and plasma samples will be collected at predefined time points for up to 48 hours after dosing to characterize zoliflodacin concentrations and estimate drug exposure in breast milk and maternal plasma. Participants will temporarily discontinue breastfeeding from study check-in until 72 hours after dosing to avoid infant exposure to zoliflodacin. Breast milk will be expressed using an electronic breast pump and collected according to the study schedule. Participants will be admitted to the clinical research unit the day before dosing and discharged after completion of the 48-hour PK sampling period. A follow-up visit will be conducted approximately 7 days after dosing to assess safety and tolerability. A lactation consultant will be available throughout the study period and for up to 30 days after dosing, as needed.

Eligibility

Age range

18–45 years

Sex

Female

Healthy volunteers

Yes