A Phase 1 Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery and Metabolite Profile and to Identify Metabolite Structures for [14C]-CORT125281 in Healthy Subjects

Corcept Therapeutics1 site in 1 country6 target enrollmentSeptember 13, 2018

ConditionsHealthy

Interventions14C-CORT125281

Drugs14C-CORT125281

Overview

Phase: Phase 1
Intervention: 14C-CORT125281
Conditions: Healthy
Sponsor: Corcept Therapeutics
Enrollment: 6
Locations: 1
Primary Endpoint: Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281
Status: Completed
Last Updated: 7 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-CORT125281 in healthy participants.

Registry

clinicaltrials.gov

Start Date

September 13, 2018

End Date

November 2, 2018

Last Updated

7 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
•Provide written informed consent
•Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
•Able to swallow capsules
•Adhere to specified contraception requirements.

Exclusion Criteria

•Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT125281 at any time
•Have a pregnant partner
•Employees or immediate family members of employees of the study site or Sponsor
•History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
•Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
•Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017; greater than background radiation exposure from other sources exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
•Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
•History of clinically significant cardiovascular, renal, hepatic, respiratory or gastrointestinal disease, neurological or psychiatric disorder
•History and/or symptoms of adrenal insufficiency or any condition that could be aggravated by glucocorticoid blockade (e.g., an autoimmune disease; allergy requiring treatment)
•Donation or loss of greater than 400 mL of blood within the previous 3 months

Arms & Interventions

Study Participants

On Day 1, participants will receive a single oral dose of 14C-CORT125281 360 mg (6 X 60 mg capsules) after an overnight fast.

Intervention: 14C-CORT125281

Outcomes

Primary Outcomes

Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281

Time Frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)

Secondary Outcomes

Plasma PK of Total Radioactivity after Oral Dosing: Mean Residence Time (MRT)(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281(Until the mass balance criteria for all participants have been met (estimated up to 10 days))
Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)(Pre-dose 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)(Pre-dose 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)(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Plasma PK of CORT125281 after Oral Dosing: tmax(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Plasma PK of CORT125281 after Oral Dosing: AUC0-last(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Plasma PK of CORT125281 after Oral Dosing: t1/2(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Plasma PK of CORT125281 after Oral Dosing: MRT(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (tmax)(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281(Until the mass balance criteria for all participants have been met (estimated up to 10 days))
Plasma PK of CORT125281 after Oral Dosing: Cmax(Pre-dose and at pre-specified time points up to Day 8 after dosing)
Number of CORT125281 Metabolites Accounting for ≥10% of Total Radioactivity Detected in Plasma, Urine, and Feces(Until the mass balance criteria for all participants have been met (estimated up to 10 days))
Percentage of Participants with One or More Adverse Events(Until the mass balance criteria for all participants have been met (estimated up to 10 days))