Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male Participants

NCT04990310 | Completed Phase 1

• 2 other identifiers: CORT113176-6512021-002544-78
• 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 \[14C\]-CORT113176 in healthy male participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176

  Until the mass balance criteria for all participants have been met (estimated up to 28 days)

Secondary Outcomes (13)

• Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176

  Until the mass balance criteria for all participants have been met (estimated up to 28 days)

• Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176

  Until the mass balance criteria for all participants have been met (estimated up to 28 days)

• Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces

  Until the mass balance criteria for all participants have been met (estimated up to 28 days)

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

  Before dosing 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)

  Before dosing 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 \[14C\]-CORT113176 450 mg (3 X 150 mg lipid formulation capsules) in the fed state.

Drug: [14C]-CORT113176

Interventions

[14C]-CORT113176 DRUG

\[14C\]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 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
• Willing and able to participate in the whole study
• Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
• Provide written informed consent
• Adhere to the contraception requirements.

You may not qualify if:

• Have received any investigational medicine in a clinical research study within 90 days
• Are, or are immediate family members of, a study site or sponsor employee
• Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
• History of any drug or alcohol abuse, or regularly consume \>21 units alcohol per week
• Current smoker or user of e-cigarettes and nicotine replacement products within the last 6 months
• Have pregnant or lactating partners
• Radiation exposure, exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
• Clinically significant abnormal results of clinical chemistry, hematology or urinalysis as judged by the investigator
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
• Active renal and/or hepatic disease
• History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
• Any form of cancer within the last 5 years (exceptions apply)
• History and/or symptoms of adrenal insufficiency
• Condition that could be aggravated by glucocorticoid antagonism or activation

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Site 01

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Hazel Hunt, Ph.D.

  Corcept Therapeutics

  STUDY DIRECTOR

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: July 27, 2021
• First Posted: August 4, 2021
• Study Start: August 18, 2021
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)