This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.
Cohort 1 will evaluate safety, tolerability, and PK of single doses of a 150-mg and a new 300-mg tablet formulation of miricorilant. Cohort 1 treatment will be randomized and open label. Optional Cohorts 2 and 3 will evaluate single- and repeated-dose administration of miricorilant using a formulation, dose, and dose-regimen determined after interim evaluation of PK and safety data from previous cohorts. Cohort 2 and 3 treatments will be randomized, blinded, and placebo controlled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Miricorilant 300 mg tablets for oral administration
Miricorilant 150 mg tablets for oral administration
Placebo to match miricorilant 150 mg tablets for oral administration
Quotient Sciences
Ruddington, Nottingham, United Kingdom
Percentage of Participants with One or More Adverse Events
Time frame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Percentage of Participants with One or More Serious Adverse Events
Time frame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Percentage of Participants Discontinued from the Study due to an Adverse Event
Time frame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Plasma Pharmacokinetics (PK) of Miricorilant: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
Plasma PK of Miricorilant: Maximum Observed Concentration (Cmax)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Plasma PK of Miricorilant: Time from Dosing at which Cmax was Apparent (Tmax)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Plasma PK of Miricorilant: Apparent Elimination Half-life (t1/2)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
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Plasma PK of Miricorilant: Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-last)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
Plasma PK of Miricorilant: Area Under the Curve from Time Zero to 24 Hours Postdose (AUC0-24)
Time frame: Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)