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

March 14, 2019 updated by: Corcept Therapeutics

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

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.

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.

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.
6

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
    • Nottingham
      • Ruddington, Nottingham, United Kingdom, NG11 6JS
        • Quotient Sciences

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

No

Genders Eligible for Study

Male

Description

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.

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: Study Participants
On Day 1, participants will receive a single oral dose of 14C-CORT125281 360 mg (6 X 60 mg capsules) after an overnight fast.
Drug: 14C-CORT125281
14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C

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
Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281
Time Frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Until the mass balance criteria for all participants have been met (estimated up to 10 days)

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
Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281
Time Frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281
Time Frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (tmax)
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
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)
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2)
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of Total Radioactivity after Oral Dosing: Mean Residence Time (MRT)
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: Cmax
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: tmax
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: AUC0-last
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: t1/2
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT125281 after Oral Dosing: MRT
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing
Time Frame: Pre-dose and at pre-specified time points up to Day 8 after dosing
Pre-dose and at pre-specified time points up to Day 8 after dosing
Number of CORT125281 Metabolites Accounting for ≥10% of Total Radioactivity Detected in Plasma, Urine, and Feces
Time Frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Percentage of Participants with One or More Adverse Events
Time Frame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Until the mass balance criteria for all participants have been met (estimated up to 10 days)

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

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 (Actual)

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.
September 13, 2018

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.
November 1, 2018

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.
November 2, 2018

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).
March 14, 2019

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.
March 14, 2019

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 18, 2019

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.
March 18, 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.
March 14, 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.
March 1, 2019

More Information

Terms related to this study

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.
  • CORT125281-602
  • 2018-001700-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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