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

NCT03067376 | Completed Phase 1

• 2 other identifiers: CORT125134-1212016-000668-41
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Absorption, distribution, metabolism, and excretion (ADME); Metabolism; Metabolite Profiling; Excretion

Outcome Measures

Primary Outcomes (15)

• Amount of radioactivity eliminated in urine

  Day 1 pre-dose to Day 8 post-dose

• Amount of radioactivity eliminated in feces

  Day 1 pre-dose to Day 8 post-dose

• Amount of radioactivity eliminated in urine and feces

  Day 1 pre-dose to Day 8 post-dose

• Cumulative amount of radioactivity eliminated in urine

  Day 1 pre-dose to Day 8 post-dose

• Cumulative amount of radioactivity eliminated in feces

  Day 1 pre-dose to Day 8 post-dose

• Cumulative amount of radioactivity eliminated in urine and feces

  Day 1 pre-dose to Day 8 post-dose

• Pharmacokinetics (PK) of total radioactivity: lag time (tlag)

  Day 1 pre-dose to Day 8 post-dose

• PK of total radioactivity: peak plasma concentration (Cmax)

  Day 1 pre-dose to Day 8 post-dose

• PK of total radioactivity: time to reach maximum observed concentration (tmax)

  Day 1 pre-dose to Day 8 post-dose

• 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

• 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

• 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

• 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

• PK of total radioactivity: elimination half-life (t1/2)

  Day 1 pre-dose to Day 8 post-dose

• Metabolic profiling and structural identification in plasma, urine and feces

  Day 1 pre-dose to Day 8 post-dose

Secondary Outcomes (22)

• Hematology

  Screening, Day 1 pre-dose, Day 8

• Clinical chemistry

  Screening, Day 1 pre-dose, Day 8

• Urinalysis

  Screening, Day 1 pre-dose, Day 8

• Blood pressure

  Screening, Day 1 pre-dose and 2 hours post-dose, Day 8

• Heart rate

  Screening, Day 1 pre-dose and 2 hours post-dose, Day 8

Study Arms (1)

[14C]-CORT125134

EXPERIMENTAL

Two capsules each containing 125 milligrams (mg) \[14C\]-CORT125134 administered to each participant on 1 occasion

Drug: [14C]-CORT125134

Interventions

[14C]-CORT125134 DRUG

[14C]-CORT125134

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Quotient Clinical

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

Study Officials

• Pui Leung, MBChB

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: March 1, 2017
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)