The purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants will receive single dose of oral Etavopivat in each treatment period.
ICON-Salt Lake City
Salt Lake City, Utah, United States
AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Measured as hours nanograms per milliliter (h\*ng/mL).
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose
Measured as nanograms per milliliter (ng/mL).
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration
Measured as hours nanograms per milliliter (h\*ng/ml).
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose
Measured as hours.
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
t1/2, etavopivat: Terminal half-life for etavopivat after a single dose
Measured as hours.
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose
Measured as liter per hours (L/h).
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
Measured as liters (L).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
Number of adverse events
Measured as count of events.
Time frame: From IMP administration on day 1 to completion of the end of study visit (V10)