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First received: January 25, 2023

Clinical Trial: Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Antipsychotic Induced Weight Gain

Study Type: INTERVENTIONAL


Official Title: A Phase 1, Open-Label, Fixed-Sequence Crossover Study to Evaluate the Effect of a Strong Inhibitor of Cytochrome P450 2C19 on the Pharmacokinetics of Miricorilant in Healthy Subjects

Brief Summary: 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…

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