Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

Corcept Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: 14C-CORT118335 oral

Drug: CORT118335 Oral

Drug: 14C-CORT118335 intravenous

Study type

Interventional

Funder types

Industry

Identifiers

NCT03878264

2018-001507-36 (EudraCT Number)

CORT118335-851

Details and patient eligibility

About

This study will evaluate the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures following a single oral dose of CORT118335 in healthy male participants.

Enrollment

12 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18 to 65 years of age for Part 1 and 30 to 65 years of age for Part 2
Body mass index of 18.0 to 30.0 kg/m^2
Provide written informed consent
Have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) for Part 2
Adhere to the contraception requirements.

Exclusion criteria

Have received any investigational medicine in a clinical research study within the previous 3 months or CORT118335 at any time
Employees or immediate family members of employees of the study site or Sponsor
Have a pregnant partner
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, endocrine, metabolic, respiratory, neurological, or gastrointestinal disease
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 past 3 months
Has consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
Are taking, or have taken, any prescribed, over-the-counter drug or vitamins/herbal remedies within 14 days (longer restrictions apply for some medicines).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Part 1

Experimental group

Description:

On Day 1, participants will receive a single oral dose of CORT118335 900 mg (Treatment A) after an overnight fast, and a 15-minute intravenous infusion of a microdose of 14C-CORT118335 (Treatment B) beginning 2 hours 45 minutes after the oral dose is administered.

Treatment: