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

A Phase 1 Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery and Metabolite Profile and to Identify Metabolite Structures for [14C]-CORT125281 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 14C-CORT125281

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 14C-CORT125281; 14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2)	Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of Total Radioactivity after Oral Dosing: Mean Residence Time (MRT)	Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: Cmax	Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: tmax	Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: AUC0-last	Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: t1/2	Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: MRT	Pre-dose and at pre-specified time points up to Day 8 after dosing
Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing	Pre-dose and at pre-specified time points up to Day 8 after dosing
Number of CORT125281 Metabolites Accounting for ≥10% of Total Radioactivity Detected in Plasma, Urine, and Feces	Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Percentage of Participants with One or More Adverse Events	Until the mass balance criteria for all participants have been met (estimated up to 10 days)

Collaborators and Investigators

• Sponsor: Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 2, 2018

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CORT125281-602; 2018-001700-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No