Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT04793204
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2021-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects
Sponsor:
Astellas Pharma China, Inc.
Organization:
Study Overview
Official Title:
Pharmacokinetic Study of Fezolinetant - An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects
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 pharmacokinetics and safety of fezolinetant after single-dose and multiple dose administration in healthy Chinese female participants.
Detailed Description:
Participants will undergo screening evaluations to determine their eligibility within 21 days prior to the study enrollment.
Participants will be admitted to the clinical unit a day before administration (day -1) and will be confined in the clinical unit until 48 hours after last administration (day 18).
Participants will be admitted to the clinical unit a day before administration (day -1) and will be confined in the clinical unit until 48 hours after last administration (day 18).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: