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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]-CORT113176

• Registration Number: NCT04990310
• Lead Sponsor: Corcept Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-04
• Study Start: 2021-08-18
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• 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.

Read More

Exclusion Criteria

• 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
• Donation of blood or plasma 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 herbal remedies (other than up to 4 g of paracetamol per day) within 14 days. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis.
• Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
• Additional criteria apply.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Participants	[14C]-CORT113176	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
Plasma PK of CORT113176 after Oral Dosing: Tmax	Before dosing and at pre-specified time points up to Day 8 after dosing
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)
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: Area Under the Plasma Concentration-time Curve from Zero Time to Time of the Last Measurable Concentration (AUC0-last)	Before dosing 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)	Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: Cmax	Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: AUC0-last	Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: t1/2	Before dosing and at pre-specified time points up to Day 8 after dosing
Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing	Before dosing and at pre-specified time points up to Day 8 after dosing
Number of Participants with One or More Adverse Events	Until the mass balance criteria for all participants have been met (estimated up to 28 days)

Trial Locations

Locations (1)

Site 01; 🇬🇧 Ruddington, Nottingham, United Kingdom