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

Healthy Clinical Trial

Official title:

An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-CORT113176 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990310
• Other study ID #: CORT113176-651
• Secondary ID: 2021-002544-78
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: November 2021
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]-CORT113176
[14C]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.

Locations

Country	Name	City	State
United Kingdom	Site 01	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Plasma PK of CORT113176 after Oral Dosing: Cmax		Before dosing and at pre-specified time points up to Day 8 after dosing
Secondary	Plasma PK of CORT113176 after Oral Dosing: Tmax		Before dosing and at pre-specified time points up to Day 8 after dosing
Secondary	Plasma PK of CORT113176 after Oral Dosing: AUC0-last		Before dosing and at pre-specified time points up to Day 8 after dosing
Secondary	Plasma PK of CORT113176 after Oral Dosing: t1/2		Before dosing and at pre-specified time points up to Day 8 after dosing
Secondary	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
Secondary	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)