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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641260
• Other study ID #: 2693-CL-0012
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2020
• Est. completion date: February 21, 2021

Study information

• Verified date: February 2022
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 21, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Fezolinetant
Oral

Locations

Country	Name	City	State
United States	Parexel	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.	up to Day 18
Secondary	Number of participants with laboratory value abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant laboratory values.	up to Day 18
Secondary	Number of participants with vital sign abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant vital sign values.	up to Day 18
Secondary	Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)	Number of participants with potentially clinically significant electrocardiogram (ECG) values.	up to Day 18