The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe) compared to healthy female participants with normal renal function. This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with varying levels of renal impairment (mild, moderate and severe) and healthy female participants with normal renal function. Renal function will be measured by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula: Mild (eGFR 60 to \< 90 mL/min per 1.73 m\^2) renal impairment; moderate (eGFR 30 to \< 60 mL/min per 1.73 m\^2) renal impairment, severe (eGFR \< 30 mL/min per 1.73 m\^2) renal impairment and not on hemodialysis and normal (eGFR ≥ 90 mL/min per 1.73 m\^2) renal function.
This study will be comprised of four groups of participants based on renal function. Participants will be screened for up to 28 days prior to investigational product (IP) administration on Day 1. Eligible participants with mild, moderate and severe renal function and healthy participants with normal renal function will be admitted to the clinical unit on Day -1 and will be residential for a single period of six days/five nights. On Day 1, participants will receive a single oral dose of fezolinetant under fasting conditions followed by a 96-hour in-house blood and urine sampling period. Participants are to remain awake, seated or semirecumbent and avoid lying on either the left or right side for at least four hours postdose. Standard safety and tolerability assessments will be conducted. Participants will be discharged from the clinical unit on Day 5 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 five to nine days after the last pharmacokinetic sample is collected or at early discontinuation from the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Oral
National Institute of Clinical Research
Garden Grove, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Prism research, LLC
Saint Paul, Minnesota, 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 PK plasma samples collected.
Time frame: Up to 5 days
PK of Fezolinetant in Plasma: AUC From the Time of Dosing to the Last Measurable Concentration (AUClast)
AUClast will be recorded from the PK plasma samples collected.
Time frame: Up to 5 days
PK of Fezolinetant in Plasma: Maximum Concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Time frame: Up to 5 days
PK of Fezolinetant in Plasma: Apparent Clearance (CL/F)
CL/F will be recorded from the PK plasma samples collected.
Time frame: Up to 5 days
PK of Fezolinetant Metabolite ES259564 in Plasma: AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Time frame: Up to 5 days
PK of Fezolinetant Metabolite ES259564 in Plasma: AUClast
AUClast will be recorded from the PK plasma samples collected.
Time frame: Up to 5 days
PK of Fezolinetant Metabolite ES259564 in Plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Time frame: Up to 5 days
Number of Participants With Adverse Events (AEs)
AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an IP and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 14 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 14 days
Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 14 days
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant 12-ECG values.
Time frame: Up to 14 days
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