The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 \[(CYP) 2C19\] inhibitor, fluvoxamine, in healthy participants. Participants will receive a single dose of miricorilant under fed conditions with a standard breakfast after an overnight fast alone and in combination with once-daily doses of fluvoxamine. Blood samples will be collected at regular intervals for PK and safety analysis between admission and discharge from the clinical unit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Miricorilant 6 x 100 mg coated tablets
Fluvoxamine 50 mg tablet
Site 01
Miami, Florida, United States
Maximum observed plasma concentration of miricorilant (Cmax)
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
Area under the curve from time zero to the time of last measurable plasma concentration of miricorilant (AUC0-last)
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
Area under the curve from time zero extrapolated to infinity of plasma concentration of miricorilant (AUC0-inf)
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10
Number of participants with one or more treatment-emergent adverse events (TEAEs)
Time frame: Up to 30 days after study drug administration
Number of participants with one or more serious adverse events (SAEs)
Time frame: Up to 30 days after study drug administration
Number of participants with a clinically-significant vital sign abnormality
Time frame: Up to Day 13
Number of participants with a clinically-significant laboratory test abnormality
Time frame: Up to Day 13
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