A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body

Healthy Clinical Trial

Official title:

An Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067376
• Other study ID #: CORT125134-121
• Secondary ID: 2016-000668-41
• Status: Completed
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: September 2016

Study information

• Verified date: August 2019
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.

Description:

The study was conducted to determine the recovery of [14C]-CORT125134 after the administration of a single oral dose of [14C]-CORT125134, to determine the routes and rate of elimination of [14C]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood. Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces. Safety and tolerability were assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy males or healthy females of non-childbearing potential (surgically sterilized or postmenopausal [defined as a woman of with at least a 12 month history of amenorrhea with a follicle-stimulating hormone (FSH) >40 international units per liter (IU/L) in the absence of a reversible medical iatrogenic cause])

• Age 30 to 65 years of age

• A history of regular bowel movements (averaging =1 and =3 stools per day)

• Must be willing and able to communicate and participate in the whole study

• Must provide written informed consent

• Male participants must agree to use an adequate method of contraception

• Participants are willing to abide by the study restrictions

Exclusion Criteria:

• Participation in a clinical research study within the previous 3 months

• Participants who have previously been enrolled in this study or participants who have previously been treated with CORT125134

• History of any drug or alcohol abuse in the past 2 years

• Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliter (mL) of 40% spirit or a 125 mL glass of wine)

• Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 parts per million (ppm)

• Females of childbearing potential (female participants must have a negative urine pregnancy test)

• Male Participants with pregnant partners

• Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. The measurement includes exposure from the present study, and diagnostic x rays and other medical exposures, but excludes background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999.

• Positive drugs of abuse test result

• Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol) or herbal remedies in the 14 days before study drug administration. Hormone replacement therapy is not permitted

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]-CORT125134

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of radioactivity eliminated in urine		Day 1 pre-dose to Day 8 post-dose
Primary	Amount of radioactivity eliminated in feces		Day 1 pre-dose to Day 8 post-dose
Primary	Amount of radioactivity eliminated in urine and feces		Day 1 pre-dose to Day 8 post-dose
Primary	Cumulative amount of radioactivity eliminated in urine		Day 1 pre-dose to Day 8 post-dose
Primary	Cumulative amount of radioactivity eliminated in feces		Day 1 pre-dose to Day 8 post-dose
Primary	Cumulative amount of radioactivity eliminated in urine and feces		Day 1 pre-dose to Day 8 post-dose
Primary	Pharmacokinetics (PK) of total radioactivity: lag time (tlag)		Day 1 pre-dose to Day 8 post-dose
Primary	PK of total radioactivity: peak plasma concentration (Cmax)		Day 1 pre-dose to Day 8 post-dose
Primary	PK of total radioactivity: time to reach maximum observed concentration (tmax)		Day 1 pre-dose to Day 8 post-dose
Primary	PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)		Day 1 pre-dose to Day 8 post-dose
Primary	PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf)		Day 1 pre-dose to Day 8 post-dose
Primary	PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)		Day 1 pre-dose to Day 8 post-dose
Primary	PK of total radioactivity: first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve (lambda-z)		Day 1 pre-dose to Day 8 post-dose
Primary	PK of total radioactivity: elimination half-life (t1/2)		Day 1 pre-dose to Day 8 post-dose
Primary	Metabolic profiling and structural identification in plasma, urine and feces		Day 1 pre-dose to Day 8 post-dose
Secondary	Hematology		Screening, Day 1 pre-dose, Day 8
Secondary	Clinical chemistry		Screening, Day 1 pre-dose, Day 8
Secondary	Urinalysis		Screening, Day 1 pre-dose, Day 8
Secondary	Blood pressure		Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Secondary	Heart rate		Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Secondary	Electrocardiogram		Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Secondary	Percentage of subjects with adverse events		Screening to Day 28
Secondary	Physical examination		Screening and Day 8
Secondary	Tlag of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	Cmax of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	Tmax of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	AUClast of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	%AUCextrap of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	AUCinf of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	Lambda-z of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	T1/2 of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	Mean Residence Time (MRT) of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	Apparent oral clearance (CL/F) of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	Apparent volume of distribution (Vz/F) of CORT125134		Day 1 pre-dose to Day 8 post-dose
Secondary	Number of metabolites >10% of circulating radioactivity in plasma		Day 1 pre-dose to Day 8 post-dose
Secondary	Number of metabolites >10% of the dose in urine		Day 1 pre-dose to Day 8 post-dose
Secondary	Number of metabolites >10% of the dose in feces		Day 1 pre-dose to Day 8 post-dose