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Healthy SubjectsPhase 1NCT04641260

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

A Phase 1 study testing Fezolinetant in people with Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
Fezolinetant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
20 Nov 2020to 21 Feb 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parexel

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Fezolinetant
Keywords
Pharmacokinetics of Fezolinetant, Effect of Food, ESN364

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FezolinetantDrug

    Also called ESN364

    Oral

Study groups in NCT04641260
Study groupRoleWhat they receive
Fezolinetant: Fed State then Fasted StateExperimentalParticipants 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.
Receives: Drug: Fezolinetant
Fezolinetant: Fasted State then Fed StateExperimentalParticipants 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.
Receives: Drug: Fezolinetant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to Day 4 in each study period.

  2. 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.

    Measured: up to Day 4 in each study period.

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

    Cmax will be recorded from the PK plasma samples collected.

    Measured: up to Day 4 in each study period.

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

    Tmax will be recorded from the PK plasma samples collected.

    Measured: up to Day 4 in each study period.

Secondary outcomes (4)

  1. Number of participants with Adverse Events (AEs)

    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.

    Measured: up to Day 18

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

    Number of participants with potentially clinically significant laboratory values.

    Measured: up to Day 18

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

    Number of participants with potentially clinically significant vital sign values.

    Measured: up to Day 18

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

    Number of participants with potentially clinically significant electrocardiogram (ECG) values.

    Measured: up to Day 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start20 Nov 2020
  3. Primary completion12 Feb 2021
  4. Study completion21 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04641260
Sponsor's protocol ID
2693-CL-0012
Status last verified
Oct 2024
First submitted
20 Nov 2020
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fezolinetant in people with Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04641260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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