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Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects
Sponsor: Corcept Therapeutics
Summary
This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2025-09-11
Completion Date
2025-12-13
Last Updated
2025-11-20
Healthy Volunteers
Yes
Conditions
Interventions
Miricorilant Treatment A
Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration
Miricorilant Treatment B
Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration
Miricorilant Treatment C
Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration
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.
Locations (1)
Site 01
Miami, Florida, United States