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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877952
• Other study ID #: CORT125281-602
• Secondary ID: 2018-001700-11
• Status: Completed
• Phase: Phase 1
• Start date: September 13, 2018
• Est. completion date: November 2, 2018

Study information

• Verified date: March 2019
• 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-CORT125281 in healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2, 2018
• Est. primary completion date: November 1, 2018
• 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

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	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 Oral Dose of 14C-CORT125281		Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
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)		Pre-dose 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)		Pre-dose and at pre-specified time points up to Day 8 after dosing
Secondary	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
Secondary	Plasma PK of CORT125281 after Oral Dosing: Cmax		Pre-dose and at pre-specified time points up to Day 8 after dosing
Secondary	Plasma PK of CORT125281 after Oral Dosing: tmax		Pre-dose and at pre-specified time points up to Day 8 after dosing
Secondary	Plasma PK of CORT125281 after Oral Dosing: AUC0-last		Pre-dose and at pre-specified time points up to Day 8 after dosing
Secondary	Plasma PK of CORT125281 after Oral Dosing: t1/2		Pre-dose and at pre-specified time points up to Day 8 after dosing
Secondary	Plasma PK of CORT125281 after Oral Dosing: MRT		Pre-dose and at pre-specified time points up to Day 8 after dosing
Secondary	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
Secondary	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)
Secondary	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)