Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2018-11-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

14C-CORT125281

Intervention Type DRUG

14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C

Interventions

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14C-CORT125281

14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C

Intervention Type DRUG

Eligibility Criteria

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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
* Are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies within 1 week (longer restrictions apply for some medicines).

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes