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.
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. Premenopausal female participants will be admitted to the clinical unit during days 1 to 3 of their menstrual cycle. Participants will receive a single dose of test formulation or reference formulation under fasting conditions on day 1 of each period i.e., days 2 to 4 (period 1) and days 7 to 9 (period 2) of their menstrual cycle for premenopausal female participants. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
Administered orally
Administered orally
PAREXEL Early Phase Clinical Unit
Baltimore, Maryland, United States
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 pharmacokinetic (PK) plasma samples collected
Time frame: Up to 72 hours postdose 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)
AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected
Time frame: Up to 72 hours postdose in each study period
Pharmacokinetics (PK) of fezolinetant in plasma: Maximum concentration (Cmax)
Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected
Time frame: Up to 72 hours postdose in each study period
Number of participants with Adverse Events (AEs)
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.
Time frame: Up to 19 days
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 19 days
Number of participants with vital sign abnormalities and/or adverse events (AEs)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 19 days