Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:43 AM
Study NCT ID:
NCT04641260
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2020-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants
Sponsor:
Astellas Pharma Global Development, Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Fezolinetant in Healthy Female Participants
Status:
COMPLETED
Status Verified Date:
2024-10
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:
The purpose of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of fezolinetant under fasted and fed conditions in healthy female participants. The study will also evaluate the safety and tolerability of a single oral dose of fezolinetant under fasted and fed conditions in healthy female participants.
Detailed Description:
Each participant will participate in 2 treatment periods separated by a washout of at least 5 days between investigational product (IP) administration in each period. Participants will be admitted to the clinical unit on day -1 of period 1 and will be in clinical unit for periods 1 and 2. On day 1 of each period, participants will receive fezolinetant followed by a 72-hour blood sampling period. The study will be completed with an end-of-study visit (ESV) which will take place 5 to 9 days after the 72-hour blood sampling period in period 2 or at the time of early discontinuation from the study.
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?:
None
Is an FDA AA801 Violation?: