NCT06094712

A Study to Evaluate the Pharmacokinetics of the CORT125134 Phase 2 Formulation in Healthy Male Subjects

An Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of the Phase 2 Formulation of CORT125134 Capsules in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study designed to characterize the pharmacokinetic (PK) profile of CORT125134 following a single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male subjects.

Detailed description

Following an overnight fast, subjects will be administered a single 150-mg oral dose of CORT125134 capsules on the morning of Day 1. Blood samples for determination of PK parameters will be collected predose and at serial time points up to 120 hours after study drug administration. The secondary objective of the study is to characterize the PK profile of metabolite CORT125201 following a single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CORT125134	CORT125134 150-mg capsule

Timeline

• Start date: 2016-04-07
• Primary completion: 2016-04-27
• Completion: 2016-04-27
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study