NCT04672499

Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Miricorilant Tablet Formulations Following Single and Multiple Oral Doses in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.

Detailed description

Cohort 1 will evaluate safety, tolerability, and PK of single doses of a 150-mg and a new 300-mg tablet formulation of miricorilant. Cohort 1 treatment will be randomized and open label. Optional Cohorts 2 and 3 will evaluate single- and repeated-dose administration of miricorilant using a formulation, dose, and dose-regimen determined after interim evaluation of PK and safety data from previous cohorts. Cohort 2 and 3 treatments will be randomized, blinded, and placebo controlled.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Miricorilant 300 mg tablets	Miricorilant 300 mg tablets for oral administration
DRUG	Miricorilant 150 mg tablets	Miricorilant 150 mg tablets for oral administration
DRUG	Placebo 150 mg tablets	Placebo to match miricorilant 150 mg tablets for oral administration

Timeline

• Start date: 2020-04-27
• Primary completion: 2020-09-07
• Completion: 2020-09-07
• First posted: 2020-12-17
• Last updated: 2020-12-17

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study