NCT04994743

Safety, Tolerability, and Pharmacokinetic Study of CORT113176 in Healthy Participants

Multiple Dose Safety, Tolerability, Plasma and Cerebrospinal-Fluid Pharmacokinetic Study of Oral Doses of CORT113176

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a safety, tolerability, and pharmacokinetic study in 2 cohorts of healthy male participants with an option for an additional cohort. Cohorts 1 and 2 will receive once daily by mouth CORT113176 150 mg and 300 mg, respectively, for 14 days under fed conditions. Progression from Cohort 1 to Cohort 2 will be done based on the safety and tolerability outcome in Cohort 1 and after Cohort 1 has received the study drug for at least 7 days. The optional Cohort 3 may receive a higher dose that will not exceed CORT113176 450 mg once daily by mouth for 14 days under fed conditions. The progression from Cohort 2 to the optional cohort (Cohort 3) will be based on the same precautions as with the progression from Cohort 1 to Cohort 2. Each participant will undergo safety evaluations. Pharmacokinetics of CORT113176 will be assessed in plasma and cerebrospinal fluid (CSF) samples. Pharmacodynamic assessments will include the measurement of serum cortisol.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	CORT113176	CORT113176 lipid capsule formulation for oral administration
DRUG	Placebo matching CORT113176	Placebo matching CORT113176 lipid capsule formulation for oral administration

Timeline

• Start date: 2021-07-13
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2021-08-06
• Last updated: 2021-10-11

Locations

1 site across 1 country: Netherlands