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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]-CORT113176

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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
• Active renal and/or hepatic disease
• History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
• Any form of cancer within the last 5 years (exceptions apply)
• History and/or symptoms of adrenal insufficiency
• Condition that could be aggravated by glucocorticoid antagonism or activation
• Donation of blood or plasma or loss of greater than 400 mL of blood within the previous 3 months
• Are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) within 14 days. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis.
• Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
• Additional criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: [14C]-CORT113176; [14C]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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)
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: Time from Dosing to Cmax (Tmax)	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: Tmax	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)

Collaborators and Investigators

• Sponsor: Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 18, 2021
• Primary Completion (ACTUAL): September 20, 2021
• Study Completion (ACTUAL): September 20, 2021

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (ACTUAL): August 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CORT113176-651; 2021-002544-78 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No