NCT03067376

A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body

An Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.

Detailed description

The study was conducted to determine the recovery of \[14C\]-CORT125134 after the administration of a single oral dose of \[14C\]-CORT125134, to determine the routes and rate of elimination of \[14C\]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood. Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces. Safety and tolerability were assessed.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]-CORT125134

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2017-03-01
• Last updated: 2019-08-09

Locations

1 site across 1 country: United Kingdom