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

NCT03877952 | Completed Phase 1

• 2 other identifiers: CORT125281-6022018-001700-11
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281

  Until the mass balance criteria for all participants have been met (estimated up to 10 days)

Secondary Outcomes (15)

• Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281

  Until the mass balance criteria for all participants have been met (estimated up to 10 days)

• Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281

  Until the mass balance criteria for all participants have been met (estimated up to 10 days)

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

  Pre-dose and at pre-specified time points up to Day 8 after dosing

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

  Pre-dose and at pre-specified time points up to Day 8 after dosing

• Plasma 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 8 after dosing

Study Arms (1)

Study Participants

EXPERIMENTAL

On Day 1, participants will receive a single oral dose of 14C-CORT125281 360 mg (6 X 60 mg capsules) after an overnight fast.

Drug: 14C-CORT125281

Interventions

14C-CORT125281 DRUG

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

Study Participants

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Sharan Sidhu, MBChB, BAO, MRCS, MFPM

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: September 13, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 2, 2018
• Last Updated: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)