Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

NCT ID: NCT03878264

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2019-03-24

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1

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.

Group Type: EXPERIMENTAL

CORT118335 Oral

Intervention Type: DRUG

CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration

14C-CORT118335 intravenous

Intervention Type: DRUG

14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C

Part 2

On Day 1, participants will receive a single oral dose of 14C-CORT118335 150 mg (Treatment C) after an overnight fast.

Group Type: EXPERIMENTAL

14C-CORT118335 oral

Intervention Type: DRUG

14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C

Interventions

CORT118335 Oral

CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration

Intervention Type: DRUG

14C-CORT118335 intravenous

14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C

Intervention Type: DRUG

14C-CORT118335 oral

14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C

Intervention Type: DRUG

Other Intervention Names

Treatment A; Treatment B; Treatment C

Eligibility Criteria

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).

• Minimum Eligible Age: 18 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

Sharan Sidhu, MBChB, BAO, MRCS, MFPM

Role: PRINCIPAL_INVESTIGATOR

Quotient Sciences

Locations

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Other Identifiers

2018-001507-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CORT118335-851

Identifier Type: -

Identifier Source: org_study_id