Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 9:52 PM
Study NCT ID:
NCT06954493
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2024-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp
Sponsor:
Scynexis, Inc.
Organization:
Study Overview
Official Title:
Phase 1, Open-Label Pharmacokinetic Study in Healthy Lactating Women After Two Oral Doses of Ibrexafungerp Administered on a Single Day
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: