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

August 7, 2019 updated by: Corcept Therapeutics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion
Drug: [14C]-CORT125134

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Amount of radioactivity eliminated in urine
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in urine and feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine and feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: peak plasma concentration (Cmax)
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: time to reach maximum observed concentration (tmax)
Time Frame: Day 1 pre-dose to Day 8 post-dose
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)
Time Frame: Day 1 pre-dose to Day 8 post-dose
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)
Time Frame: Day 1 pre-dose to Day 8 post-dose
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)
Time Frame: Day 1 pre-dose to Day 8 post-dose
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)
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: elimination half-life (t1/2)
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Metabolic profiling and structural identification in plasma, urine and feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hematology
Time Frame: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Clinical chemistry
Time Frame: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Urinalysis
Time Frame: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Blood pressure
Time Frame: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Heart rate
Time Frame: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Electrocardiogram
Time Frame: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Percentage of subjects with adverse events
Time Frame: Screening to Day 28
Screening to Day 28
Physical examination
Time Frame: Screening and Day 8
Screening and Day 8
Tlag of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cmax of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Tmax of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUClast of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
%AUCextrap of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUCinf of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Lambda-z of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
T1/2 of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Mean Residence Time (MRT) of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Apparent oral clearance (CL/F) of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Apparent volume of distribution (Vz/F) of CORT125134
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of circulating radioactivity in plasma
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in urine
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corcept Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pui Leung, MBChB, Quotient Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CORT125134-121
  • 2016-000668-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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