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HealthyPhase 1NCT03067376

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

A Phase 1 study testing [14C]-CORT125134 in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
[14C]-CORT125134
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2016to Sep 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Clinical

    Nottingham, Nottinghamshire, NG11 6JS

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions
Healthy
Being tested
[14C]-CORT125134
Keywords
Absorption, distribution, metabolism, and excretion (ADME), Metabolism, Metabolite Profiling, Excretion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-CORT125134Drug

Study groups in NCT03067376
Study groupRoleWhat they receive
[14C]-CORT125134ExperimentalTwo capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion
Receives: Drug: [14C]-CORT125134

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of radioactivity eliminated in urine

    Measured: Day 1 pre-dose to Day 8 post-dose

  2. Amount of radioactivity eliminated in feces

    Measured: Day 1 pre-dose to Day 8 post-dose

  3. Amount of radioactivity eliminated in urine and feces

    Measured: Day 1 pre-dose to Day 8 post-dose

  4. Cumulative amount of radioactivity eliminated in urine

    Measured: Day 1 pre-dose to Day 8 post-dose

  5. Cumulative amount of radioactivity eliminated in feces

    Measured: Day 1 pre-dose to Day 8 post-dose

  6. Cumulative amount of radioactivity eliminated in urine and feces

    Measured: Day 1 pre-dose to Day 8 post-dose

  7. Pharmacokinetics (PK) of total radioactivity: lag time (tlag)

    Measured: Day 1 pre-dose to Day 8 post-dose

  8. PK of total radioactivity: peak plasma concentration (Cmax)

    Measured: Day 1 pre-dose to Day 8 post-dose

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

    Measured: Day 1 pre-dose to Day 8 post-dose

  10. PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)

    Measured: Day 1 pre-dose to Day 8 post-dose

  11. PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf)

    Measured: Day 1 pre-dose to Day 8 post-dose

  12. PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)

    Measured: Day 1 pre-dose to Day 8 post-dose

  13. 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)

    Measured: Day 1 pre-dose to Day 8 post-dose

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

    Measured: Day 1 pre-dose to Day 8 post-dose

  15. Metabolic profiling and structural identification in plasma, urine and feces

    Measured: Day 1 pre-dose to Day 8 post-dose

Secondary outcomes (22)

  1. Hematology

    Measured: Screening, Day 1 pre-dose, Day 8

  2. Clinical chemistry

    Measured: Screening, Day 1 pre-dose, Day 8

  3. Urinalysis

    Measured: Screening, Day 1 pre-dose, Day 8

  4. Blood pressure

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

  5. Heart rate

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

  6. Electrocardiogram

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

  7. Percentage of subjects with adverse events

    Measured: Screening to Day 28

  8. Physical examination

    Measured: Screening and Day 8

  9. Tlag of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  10. Cmax of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  11. Tmax of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  12. AUClast of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  13. %AUCextrap of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  14. AUCinf of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  15. Lambda-z of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  16. T1/2 of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  17. Mean Residence Time (MRT) of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  18. Apparent oral clearance (CL/F) of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  19. Apparent volume of distribution (Vz/F) of CORT125134

    Measured: Day 1 pre-dose to Day 8 post-dose

  20. Number of metabolites >10% of circulating radioactivity in plasma

    Measured: Day 1 pre-dose to Day 8 post-dose

  21. Number of metabolites >10% of the dose in urine

    Measured: Day 1 pre-dose to Day 8 post-dose

  22. Number of metabolites >10% of the dose in feces

    Measured: Day 1 pre-dose to Day 8 post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study startAug 2016
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067376
Sponsor's protocol ID
CORT125134-121
Other IDs
2016-000668-41, 2016
Status last verified
Aug 2019
First submitted
6 Dec 2016
Last updated
9 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-CORT125134 in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of radioactivity eliminated in urine (time frame: Day 1 pre-dose to Day 8 post-dose). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.

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