Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

NCT03878264 | Completed Phase 1

• 2 other identifiers: CORT118335-8512018-001507-36
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Absolute Oral Bioavailability (F) of CORT118335

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

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

  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

  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

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

Secondary Outcomes (23)

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

  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)

  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)

  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)

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

• PK of Total Radioactivity in Plasma after Oral Dosing: Mean Residence Time (MRT)

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

Study Arms (2)

Part 1

EXPERIMENTAL

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.

Drug: CORT118335 Oral; Drug: 14C-CORT118335 intravenous

Part 2

EXPERIMENTAL

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

Drug: 14C-CORT118335 oral

Interventions

CORT118335 Oral DRUG

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

Also known as: Treatment A

Part 1

14C-CORT118335 intravenous DRUG

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

Also known as: Treatment B

Part 1

14C-CORT118335 oral DRUG

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

Also known as: Treatment C

Part 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

CORT118335

Study Officials

• Sharan Sidhu, MBChB, BAO, MRCS, MFPM

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: August 6, 2018
• Primary Completion: March 24, 2019
• Study Completion: March 24, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)