NCT04793204 is a Phase 1 clinical trial of fezolinetant in Healthy Volunteers, sponsored by Astellas Pharma China, Inc..

Who is sponsoring NCT04793204?

NCT04793204 is sponsored by Astellas Pharma China, Inc..

What drugs are being tested in NCT04793204?

Interventions in NCT04793204: fezolinetant.

What condition does NCT04793204 study?

NCT04793204 studies Healthy Volunteers.

Is NCT04793204 still recruiting?

NCT04793204 is currently completed. Last updated 26 October 2024.

Last reviewed 2024-10-26 · How we verify

NCT04793204

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 26 October 2024

What this trial tests

Phase 1 trial testing fezolinetant in Healthy Volunteers in 16 participants. Completed in 21 May 2021.

Timeline

24 March 2021

Primary endpoint
21 May 2021

21 May 2021

Quick facts

Lead sponsor	Astellas Pharma China, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	16
Start date	24 March 2021
Primary completion	21 May 2021
Estimated completion	21 May 2021
Sites	1 location across China

Drugs / interventions tested

fezolinetant (FEZOLINETANT) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Astellas Pharma China, Inc. — full company profile →

Who can join

Adults 18 to 45, female only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review.
Menown SJ, Tello JA. · · 2021 · cited 21× · PMID 34514552 · DOI 10.1007/s12325-021-01900-w
An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects.
Li Y, Liu Y, Iwai M, Takeuchi M, et al · · 2025 · PMID 40160966 · DOI 10.2147/dddt.s486562

Verify or expand the search:

Other trials of fezolinetant

Trials testing the same drug.

NCT05033886 — A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause · Phase 3 · completed
NCT04482270 — A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant · Phase 1 · completed
NCT04476849 — A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Partici · Phase 1 · completed
NCT04003155 — A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause · Phase 3 · completed
NCT04003389 — A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause · Phase 3 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Astellas Pharma China, Inc. trials

Trials by the same sponsor.

NCT05152628 — A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo · Phase 4 · completed
NCT05153915 — A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograf · Phase 4 · completed
NCT04995419 — A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial · Phase 2 · completed
NCT04562090 — A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder · Phase 4 · completed
NCT04501640 — A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04793204 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma China, Inc.
Last refreshed: 26 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04793204.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing