An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-CORT113176 in Healthy Male Subjects

Corcept Therapeutics1 site in 1 country6 target enrollmentAugust 18, 2021

ConditionsHealthy

Interventions[14C]-CORT113176

Drugs[14C]-CORT113176

Overview

Phase: Phase 1
Intervention: [14C]-CORT113176
Conditions: Healthy
Sponsor: Corcept Therapeutics
Enrollment: 6
Locations: 1
Primary Endpoint: Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 18, 2021

End Date

September 20, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Corcept Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body mass index 18.0 to 30.0 kg/m\^2, inclusive
•Willing and able to participate in the whole study
•Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
•Provide written informed consent
•Adhere to the contraception requirements.

Exclusion Criteria

•Have received any investigational medicine in a clinical research study within 90 days
•Are, or are immediate family members of, a study site or sponsor employee
•Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
•History of any drug or alcohol abuse, or regularly consume \>21 units alcohol per week
•Current smoker or user of e-cigarettes and nicotine replacement products within the last 6 months
•Have pregnant or lactating partners
•Radiation exposure, exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
•Clinically significant abnormal results of clinical chemistry, hematology or urinalysis as judged by the investigator
•Confirmed positive drugs of abuse test result
•Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results

Arms & Interventions

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.

Intervention: [14C]-CORT113176

Outcomes

Primary Outcomes

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)

Secondary Outcomes

Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (Tmax)(Before dosing and at pre-specified time points up to Day 8 after dosing)
Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176(Until the mass balance criteria for all participants have been met (estimated up to 28 days))
Plasma PK of CORT113176 after Oral Dosing: Tmax(Before dosing and at pre-specified time points up to Day 8 after dosing)
Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176(Until the mass balance criteria for all participants have been met (estimated up to 28 days))
Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces(Until the mass balance criteria for all participants have been met (estimated up to 28 days))
Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)(Before dosing and at pre-specified time points up to Day 8 after dosing)
Plasma PK of Total Radioactivity after Oral Dosing: Area Under the Plasma Concentration-time Curve from Zero Time to Time of the Last Measurable Concentration (AUC0-last)(Before dosing and at pre-specified time points up to Day 8 after dosing)
Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2)(Before dosing and at pre-specified time points up to Day 8 after dosing)
Plasma PK of CORT113176 after Oral Dosing: Cmax(Before dosing and at pre-specified time points up to Day 8 after dosing)
Plasma PK of CORT113176 after Oral Dosing: AUC0-last(Before dosing and at pre-specified time points up to Day 8 after dosing)
Plasma PK of CORT113176 after Oral Dosing: t1/2(Before dosing and at pre-specified time points up to Day 8 after dosing)
Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing(Before dosing and at pre-specified time points up to Day 8 after dosing)
Number of Participants with One or More Adverse Events(Until the mass balance criteria for all participants have been met (estimated up to 28 days))