The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Participants will receive a single dose of etavopivat orally.
Cure Clinical Research LLC
Orange, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Amer. Rrsch Corp-TX Liver Inst
San Antonio, Texas, United States
Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat)
Measured in hours\*nanogram per milliter (h\*ng/mL).
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat)
Measured in nanogram per milliter (ng/mL).
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat)
Measured in h\*ng/mL.
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat)
Measured in hours.
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Terminal half-life for etavopivat after a single dose (t1/2, etavopivat)
Measured in hours.
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat)
Measured in liter per hour (L/h).
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat)
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Pinnacle Clinical Research
San Antonio, Texas, United States
Measured in liter (L).
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Number of adverse events (AEs)
Measured as count of events.
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)