At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 5 enrolled
Drug / intervention
Ibrexafungerpdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1, Open-Label Pharmacokinetic Study in Healthy Lactating Women After Two Oral Doses of Ibrexafungerp Administered on a Single Day
In Brief
A Phase 1 clinical trial evaluating Ibrexafungerp for Vulvovaginal Candidiasis and 2 related conditions. Completed, enrolled 5 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartJul 2023
Primary CompletionNov 2023
First PostedMay 2025
TodayJul 2026
First PostedMay 1, 2025
Enrollment StartJul 12, 2023
Primary CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 1.2 years ago
Interventions
Ibrexafungerpdrug
Ibrexafungerp Oral Tablet