drugset / Trial / NCT05712265

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

NCT05712265

Phase 1 Completed 26 enrolled Corcept Therapeutics
NaSingle-groupOpen-labelTreatment

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 the clinical unit.

Timeline

Start
2023-01-24
Primary completion
2023-02-23
Completion
2023-02-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluvoxamine Unknown 50 mg Oral
Subject Miricorilant Small molecule 600 mg Oral