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

NCT ID: NCT04990310

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2021-09-20

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

[14C]-CORT113176

Intervention Type: DRUG

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

Interventions

[14C]-CORT113176

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

Intervention Type: DRUG

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
• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hazel Hunt, Ph.D.

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

Site 01

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Other Identifiers

2021-002544-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CORT113176-651

Identifier Type: -

Identifier Source: org_study_id