NCT03878264

Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

An Open-label, 2-part Study Designed to Assess the Absolute Bioavailability of CORT118335 and Determine the Mass Balance Recovery, Absorption, Metabolism and Elimination, and Metabolite Profile and Identification of Metabolite Structures of [14C]-CORT118335 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures following a single oral dose of CORT118335 in healthy male participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CORT118335 Oral	CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration
DRUG	14C-CORT118335 intravenous	14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C
DRUG	14C-CORT118335 oral	14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C

Timeline

• Start date: 2018-08-06
• Primary completion: 2019-03-24
• Completion: 2019-03-24
• First posted: 2019-03-18
• Last updated: 2019-06-11

Locations

1 site across 1 country: United Kingdom