NCT07240116

Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects

An Open-Label, Randomized, 3-Treatment, 3-Period, 6-Sequence, Balanced Crossover Study to Characterize the Relative Bioavailability of Miricorilant Administered as 50-mg and 100-mg Kinetisol Tablets vs the 50-mg Spray Dried Dispersion Tablet Formulation With an Optional Food Effect Assessment in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Miricorilant Treatment A	Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration
DRUG	Miricorilant Treatment B	Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration
DRUG	Miricorilant Treatment C	Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration
DRUG	Miricorilant Treatment D	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.

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-03-03
• Completion: 2026-03-03
• First posted: 2025-11-20
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study