Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

Corcept Therapeutics12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CORT118335 OralDRUG

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

14C-CORT118335 intravenousDRUG

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

14C-CORT118335 oralDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Outcomes

Primary Outcomes

Absolute Oral Bioavailability (F) of CORT118335

Time frame: Predose and at pre-specified time points up to Day 12

Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT118335

Time frame: Until the mass balance criteria have been met by all participants (estimated Day 17)

Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT118335

Time frame: Until the mass balance criteria have been met by all participants (estimated Day 17)

Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT118335

Time frame: Until the mass balance criteria have been met by all participants (estimated Day 17)

Secondary Outcomes

Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)

Time frame: Pre-dose and at pre-specified time points up to Day 15 after dosing

PK of Total Radioactivity in Plasma after Oral Dosing: Time from Dosing to Cmax (tmax)

Time frame: Pre-dose and at pre-specified time points up to Day 15 after dosing

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)

Time frame: Pre-dose and at pre-specified time points up to Day 15 after dosing

PK of Total Radioactivity in Plasma after Oral Dosing: Apparent Elimination Half-life (t1/2)

Time frame: Pre-dose and at pre-specified time points up to Day 15 after dosing

Data from ClinicalTrials.gov

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