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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corcept Therapeutics

Criteria

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