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

October 17, 2024 updated by: Astellas Pharma Global Development, Inc.

A Phase 1 Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Fezolinetant in Healthy Female Participants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Each participant will participate in 2 treatment periods separated by a washout of at least 5 days between investigational product (IP) administration in each period. Participants will be admitted to the clinical unit on day -1 of period 1 and will be in clinical unit for periods 1 and 2. On day 1 of each period, participants will receive fezolinetant followed by a 72-hour blood sampling period. The study will be completed with an end-of-study visit (ESV) which will take place 5 to 9 days after the 72-hour blood sampling period in period 2 or at the time of early discontinuation from the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Parexel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Participant has a history of consuming > 7 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the participant tests positive for alcohol at screening or on day -1 of period 1.
  • Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 of period 1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1 of period 1.
  • Participant has used any inducer of cytochrome P450 (CYP) 1A2 in the 3 months prior or inhibitors of CYP 1A2 in the 2 weeks or 5 half-lives of the inhibitor, whichever is longer, prior to day -1 of period 1.
  • Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day 1 and/or received a transfusion of any blood or blood products within 60 days.
  • Participant has a positive serology test for hepatitis A virus antibodies (immunoglobulin M), hepatitis B core antibodies, hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
  • Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fezolinetant: Fed State then Fasted State
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
Oral
Other Names:
  • ESN364
Experimental: Fezolinetant: Fasted State then Fed State
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
Oral
Other Names:
  • ESN364

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of fezolinetant in plasma: Area under the concentration-time Curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
Time Frame: up to Day 4 in each study period.
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)
Time Frame: up to Day 4 in each study period.
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)
Time Frame: up to Day 4 in each study period.
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)
Time Frame: up to Day 4 in each study period.
Tmax will be recorded from the PK plasma samples collected.
up to Day 4 in each study period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events (AEs)
Time Frame: up to Day 18
An AE is any untoward medical occurrence in a participant administered an IP, whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP. This includes events related to the comparator and events related to the (study) procedures.
up to Day 18
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time Frame: up to Day 18
Number of participants with potentially clinically significant laboratory values.
up to Day 18
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Time Frame: up to Day 18
Number of participants with potentially clinically significant vital sign values.
up to Day 18
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Time Frame: up to Day 18
Number of participants with potentially clinically significant electrocardiogram (ECG) values.
up to Day 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Executive Director, Astellas Pharma Global Development, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2693-CL-0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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