A Phase 1 interventional study of Miricorilant and Fluvoxamine in Antipsychotic Induced Weight Gain and Non-alcoholic Steatohepatitis (NASH), sponsored by Corcept Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Corcept Therapeutics · Phase 1, Interventional, and Treatment
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.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 4 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 9 (29%) have results posted.
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Participants will receive a single oral dose of miricorilant 600 mg on Days 1 and 10 and a single oral dose of fluvoxamine 50 mg on Days 4 to 12.
Drug: Miricorilant · Drug: Fluvoxamine
Miricorilant 6 x 100 mg coated tablets
Also known as: CORT118335
Fluvoxamine 50 mg tablet
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
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Corcept Therapeutics