A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants

What this trial studies

The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant test formulation compared to a single dose of fezolinetant reference formulation under fasting conditions. This study will also evaluate the safety and tolerability of a single dose of fezolinetant test formulation and a single dose of fezolinetant reference formulation.

Conditions in scope

• Healthy Volunteers

Interventions

• fezolinetant - test formulation (Drug) — Administered orally
• fezolinetant - reference formulation (Drug) — Administered orally

Who can join

Women only · Ages 18 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Subject is a healthy female subject.
• Subject has a body mass index (BMI) range of 18.5 to 34.0 kg/m\^2, inclusive and weighs at least 50 kg at screening.
• Postmenopausal female subjects only: Subject is postmenopausal according to 1 of the following criteria:
• Spontaneous amenorrhea for ≥ 12 consecutive months
• Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (follicle-stimulating hormone \[FSH\] \> 40 IU/L); or
• Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit (with or without hysterectomy)
• Subject agrees not to participate in another interventional study while participating in the present study.
• Premenopausal female subjects only: Subject has had a regular menstrual cycle (from 25 to 31 days ± 3 days) for 3 months prior to starting the IP administration.

Exclusion criteria

• Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Subject has any condition which makes the subject unsuitable for study participation.
• Subject has a known or suspected hypersensitivity to fezolinetant or any components of the formulations used.
• Subject has had previous exposure with fezolinetant.
• Subject has any of the liver function tests (alkaline phosphatase \[ALP\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and total bilirubin \[TBL\]) \> 1.5 × upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
• Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to first investigational product (IP) administration.
• Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
• Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1
• Start date: 2020-02-20
• Primary completion: 2021-02-21
• Last update posted: 2024-10-18
• First posted: 2020-02-20

Sponsor & contact

Lead sponsor: Astellas Pharma Global Development, Inc. (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Pharmacokinetics (PK) of fezolinetant in plasma: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf) (Up to 72 hours postdose in each study period)
  AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected
• Pharmacokinetics (PK) of fezolinetant in plasma: Area under the concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast) (Up to 72 hours postdose in each study period)
  AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected
• Pharmacokinetics (PK) of fezolinetant in plasma: Maximum concentration (Cmax) (Up to 72 hours postdose in each study period)
  Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected

Related ClearedRx care

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