NCT06954493

Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp

Phase 1, Open-Label Pharmacokinetic Study in Healthy Lactating Women After Two Oral Doses of Ibrexafungerp Administered on a Single Day

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply and were between the ages of 18 and 50 years at the time of screening

Detailed description

This was a Phase 1 study designed to evaluate the pharmacokinetics of ibrexafungerp after administration of two oral doses in lactating women to determine whether ibrexafungerp is excreted in breast milk, and if so, to characterize ibrexafungerp PK in the breast milk and plasma of lactating women. Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H). Participants received both doses on site. Participants were admitted to the clinic on Day 1 and discharged on Day 5, after the 108-hour procedures were completed.

Conditions

• Vulvovaginal Candidiasis
• Candida Infection
• Vaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Ibrexafungerp	Ibrexafungerp Oral Tablet

Timeline

• Start date: 2023-07-12
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2025-05-01
• Last updated: 2025-08-08
• Results posted: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study