This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.
This study will evaluate relative bioavailability of Kinetisol and spray dried dispersion (SDD) miricorilant (CORT118335) tablets. This study will consist of 6 possible treatment sequences across 3 periods for healthy, fed participants. A fourth period may be added to assess the impact of fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration
Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration
Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration
Site 01
Miami, Florida, United States
Time of Maximum Observed Concentration (Tmax) of Miricorilant
Time frame: Predose and at serial timepoints up to 72 hours postdose
Maximum Observed Concentration (Cmax) of Miricorilant
Time frame: Predose and at serial timepoints up to 72 hours postdose
Concentration at 24 Hours Postdose (C24) of Miricorilant
Time frame: Predose and at serial timepoints up to 24 hours postdose
Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC[0-last]) of Miricorilant
Time frame: Predose and at serial timepoints up to 72 hours postdose
Area Under the Curve from Time 0 Extrapolated to Infinity (AUC[0-inf]) of Miricorilant
Time frame: Predose and at serial timepoints up to 72 hours postdose
Terminal Elimination Half-Life (T1/2) of Miricorilant
Time frame: Predose and at serial timepoints up to 72 hours postdose
Relative Bioavailability (Frel) for Miricorilant Based on Cmax
Time frame: Predose and at serial timepoints up to 72 hours postdose
Frel for Miricorilant based on AUC(0-last)
Time frame: Predose and at serial timepoints up to 72 hours postdose
Frel for Miricorilant Based on AUC(0-inf)
Time frame: Predose and at serial timepoints up to 72 hours postdose
Number of Participants with Abnormal, Clinically Significant Clinical Laboratory Findings
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Miricorilant 100 mg (1 x 100 mg or 2 x 50 mg) Kinetisol IR tablet for oral administration. The tablet strength administered will be decided after Period 3 is complete.
Clinical laboratory findings include hematology, clinical chemistry, urinalysis.
Time frame: Day -1 and 72 hours postdose in periods 3 and 4
Number of Participants with Abnormal, Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
Time frame: Day -1, predose, and at 4 and 72 hours postdose in every study period
Number of Participants with Abnormal, Clinically Significant Vital Sign Findings
Time frame: Day -1, predose, and at serial time points up to 72 hours postdose in every study period
Number of Participants with Abnormal, Clinically Significant Physical Exam Findings
Time frame: 72 hours postdose in periods 3 and 4
Number of Participants with 1 or More Adverse Events
Time frame: Screening up to 30 days postdose