A Phase 1 Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Fezolinetant in Healthy Female Participants
Overview
- Phase
- Phase 1
- Intervention
- Fezolinetant
- Conditions
- Healthy Subjects
- Sponsor
- Astellas Pharma Global Development, Inc.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK) of fezolinetant in plasma: Maximum concentration (Cmax)
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
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
- •In such a case, the assessment may be repeated once.
- •Participant has creatinine level outside normal limits on day -1 of period
- •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.
Arms & Interventions
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.
Intervention: Fezolinetant
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.
Intervention: Fezolinetant
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)(up to Day 18)
- Number of participants with 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 laboratory value abnormalities and/or adverse events (AEs)(up to Day 18)