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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04277624
Recruitment Status : Suspended (Due to COVID-19.)
First Posted : February 20, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: fezolinetant - test formulation Drug: fezolinetant - reference formulation Phase 1

Detailed Description:

Each participant will participate in 2 study periods separated by a washout of at least 5 days between investigational product (IP) administrations. Participants will be randomized to 1 of 2 sequences: either fezolinetant test formulation followed by fezolinetant reference formulation or fezolinetant reference formulation followed by fezolinetant test formulation. Participants will be admitted to the clinical unit on day -1 and will be residential for 2 study periods for a total of 10 days/9 nights. Participants will receive a single dose of test formulation or reference formulation under fasting conditions on day 1 of each period. Participants are to remain semirecumbent and avoid lying on either the left or right side for 4 hours postdose. Pharmacokinetic samples will be collected predose on day 1 of each period and at multiple time points postdose. Standard safety and tolerability assessments will be conducted. Participants will be discharged from the clinical unit on day 4 of period 2 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit.

The study will be completed with an end-of-study visit (ESV). The ESV will take place 5 to 9 days after discharge from period 2 or at early discontinuation from the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Crossover Study to Assess the Bioequivalence of Fezolinetant Following a Single Dose of Fezolinetant (Test Formulation) Compared to a Single Dose of Fezolinetant (Reference Formulation) in Healthy Postmenopausal Female Subjects
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Fezolinetant: Test Formulation then Reference Formulation
Participants will receive a single oral dose of fezolinetant test formulation on day 1 of study period 1. After a washout of 5 days the participants will receive a single oral dose of fezolinetant reference formulation on day 1 of study period 2.
Drug: fezolinetant - test formulation
Administered orally

Drug: fezolinetant - reference formulation
Administered orally

Experimental: Fezolinetant: Reference Formulation then Test Formulation
Participants will receive a single oral dose of fezolinetant reference formulation on day 1 of study period 1. After a washout of 5 days the participants will receive a single oral dose of fezolinetant test formulation on day 1 of study period 2.
Drug: fezolinetant - test formulation
Administered orally

Drug: fezolinetant - reference formulation
Administered orally




Primary Outcome Measures :
  1. 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 72 hours postdose in each study period ]
    AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected

  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) [ Time Frame: Up to 72 hours postdose in each study period ]
    AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected

  3. Pharmacokinetics (PK) of fezolinetant in plasma: Maximum concentration (Cmax) [ Time Frame: Up to 72 hours postdose in each study period ]
    Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected


Secondary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 19 days ]
    An AE is any untoward medical occurrence in a subject administered an investigatonal product (IP), and which does not necessarily have to have a causal relationship with this treatment. 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 whether or not considered related to the IP.

  2. Number of participants with laboratory value abnormalities and/or adverse events (AEs) [ Time Frame: Up to 19 days ]
    Number of participants with potentially clinically significant laboratory values.

  3. Number of participants with vital sign abnormalities and/or adverse events (AEs) [ Time Frame: Up to 19 days ]
    Number of participants with potentially clinically significant vital sign values.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is a healthy postmenopausal 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.
  • Female 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.

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.
  • Subject has any clinically significant abnormality following the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
  • Subject has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after subject has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
  • Subject has a mean corrected QT interval using Fridericia's formula (QTcF) of > 470 msec on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
  • Subject has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to first IP administration and for hormone replacement therapy (HRT) in the 8 weeks prior to first IP administration, except for occasional use of acetaminophen (up to 2 g/day) and topical dermatological products, including corticosteroid products.
  • Subject has smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening.
  • Subject 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 subject tests positive for alcohol at screening or on day -1.
  • Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the subject tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1.
  • Subject 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.
  • Subject 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.
  • Subject 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.
  • Subject is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277624


Locations
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United States, Maryland
PAREXEL Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT04277624    
Other Study ID Numbers: 2693-CL-0010
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
fezolinetant
ESN364
menopause