Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male Participants

Sponsor
Corcept Therapeutics
Study ID
NCT04990310
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
30 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • [14C]-CORT113176 — DRUG
    \[14C\]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.

Study Details

This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of \[14C\]-CORT113176 in healthy male participants.

Key Dates

First listed
Aug 4, 2021
Start date
Aug 18, 2021
Status verified
Nov 2021
Primary completion
Sep 20, 2021
Completion
Sep 20, 2021

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Study Participants
    On Day 1, participants will receive a single oral dose of \[14C\]-CORT113176 450 mg (3 X 150 mg lipid formulation capsules) in the fed state.

Primary Outcome Measure

Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176 [ Time Frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days) ]

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