A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants

NCT04641260 | Completed Phase 1 FDA Drug

• 1 other identifier: 2693-CL-0012
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Pharmacokinetics of Fezolinetant; Effect of Food; ESN364

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics (PK) of fezolinetant in plasma: Area under the concentration-time Curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)

  AUCinf will be recorded from the PK plasma samples collected.

  up to Day 4 in each study period.

• Pharmacokinetics (PK) of fezolinetant in plasma: Area under the concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast)

  AUClast will be recorded from the PK plasma samples collected.

  up to Day 4 in each study period.

• Pharmacokinetics (PK) of fezolinetant in plasma: Maximum concentration (Cmax)

  Cmax will be recorded from the PK plasma samples collected.

  up to Day 4 in each study period.

• Pharmacokinetics (PK) of fezolinetant in plasma: Time of maximum concentration (Tmax)

  Tmax will be recorded from the PK plasma samples collected.

  up to Day 4 in each study period.

Secondary Outcomes (4)

• Number of participants with Adverse Events (AEs)

  up to Day 18

• Number of participants with laboratory value abnormalities and/or adverse events (AEs)

  up to Day 18

• Number of participants with vital sign abnormalities and/or adverse events (AEs)

  up to Day 18

• Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

  up to Day 18

Study Arms (2)

Fezolinetant: Fed State then Fasted State

EXPERIMENTAL

Participants will receive a single oral dose of fezolinetant in fed state on day 1 of study period 1. After a washout of 5 days the participants will receive a single oral dose of fezolinetant in fasted state on day 1 of study period 2.

Drug: Fezolinetant

Fezolinetant: Fasted State then Fed State

EXPERIMENTAL

Participants will receive a single oral dose of fezolinetant in fasted state on day 1 of study period 1. After a washout of 5 days the participants will receive a single oral dose of fezolinetant in fed state on day 1 of study period 2.

Drug: Fezolinetant

Interventions

Fezolinetant DRUG

Oral

Also known as: ESN364

Fezolinetant: Fasted State then Fed State; Fezolinetant: Fed State then Fasted State

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant 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.
• Female participant is not pregnant and at least 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance for at least 30 days prior to day -1 of period 1 through at least 30 days after final IP administration
• Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
• Female participant must not donate ova starting at first dose of IP and throughout the study period and for 30 days after final IP administration.
• Participant agrees not to participate in another interventional study while participating in the present study.

You may not qualify if:

• Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Participant has any condition which makes the participant unsuitable for study participation.
• Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
• Participant has a known or suspected hypersensitivity to fezolinetant or any components of the formulation used.
• Participant has had previous exposure with fezolinetant.
• Participant has any of the liver function tests (alkaline phosphatase \[ALP\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and total bilirubin \[TBL\]) \> 1.5 × the upper limit of normal (ULN) on day -1 of period 1. In such a case, the assessment may be repeated once.
• Participant has creatinine level outside normal limits on day -1 of period 1. In such a case, the assessment may be repeated once.
• Participant 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 IP administration.
• Participant 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.
• Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1 of period 1.
• Participant has any clinically significant abnormality following the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1 of period 1.
• Participant has a mean pulse of \< 45 or \> 90 bpm or systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg based on the average of 3 readings. These 3 readings must occur on at least 2 different occasions during the screening period or on day -1 of period 1. Repeat measurements will not be taken during screening, but may be taken on day -1 of period 1.
• Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of \> 470 msec on day -1 of period 1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
• Participant has used any prescribed or nonprescribed drugs (including vitamins, oral contraceptives or hormone replacement therapy \[HRT\] and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to first IP administration except for occasional use of acetaminophen (up to 2 g/day) and topical dermatological products (including corticosteroid products).
• Participant has smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening or the participant tests positive for cotinine at screening or on day -1 of period 1.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

Parexel

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

fezolinetant

Study Officials

• Executive Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 23, 2020
• Study Start: November 20, 2020
• Primary Completion: February 12, 2021
• Study Completion: February 21, 2021
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)