The primary objective of the study is to evaluate the effects of a high-fat meal and of a low-fat meal on the bioavailability of relacorilant in healthy subjects.
Enrolled healthy male and female subjects will be randomized to receive 1 of 6 treatment sequences, each consisting of 3 treatments in 3 periods, in a crossover design. The 3 treatments will be a single oral dose of relacorilant 400 mg 1) under fasted conditions, 2) after a high-fat meal, and 3) after a low-fat meal. Each period will last 5 days, and a 7-day washout will follow Periods 1 and 2. Blood samples will be collected predose and at serial timepoints up to 4 days (Day 5) after dosing in each period for evaluation of the bioavailability of relacorilant. Secondary objectives of the study will be evaluation of the bioavailability of relacorilant metabolites, and evaluation of safety and tolerability of relacorilant when administered to healthy subjects under fasted and fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions
Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a high-fat meal
Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a low-fat meal
inVentiv Health Clinical Research Services LLC
Miami, Florida, United States
Area under the concentration-time curve from time zero to the last observed concentration of plasma relacorilant (AUC0-t)
Time frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
Area under the concentration-time curve from time zero extrapolated to infinity of plasma relacorilant (AUC0-inf)
Time frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
Maximal observed concentration of plasma relacorilant (Cmax)
Time frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
AUC0-t of relacorilant plasma metabolites
Time frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
AUC0-inf of relacorilant plasma metabolites
Time frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
Cmax of relacorilant plasma metabolites
Time frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
Number of subjects with one or more adverse events
Time frame: Up to Day 28
Number of subjects with one or more serious adverse events
Time frame: Up to Day 55
Number of subjects with one or more adverse events leading to study drug discontinuation
Time frame: Up to Day 25
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