NCT04793204

A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	fezolinetant	oral

Timeline

• Start date: 2021-03-24
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2021-03-11
• Last updated: 2024-10-26

Locations

1 site across 1 country: China