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HealthyPhase 1NCT03877952

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

A Phase 1 study testing 14C-CORT125281 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

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. Read more about this study

Who is it for?
Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
14C-CORT125281
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
13 Sep 2018to 2 Nov 2018
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
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Sciences

    Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Healthy
Being tested
14C-CORT125281

What participants receive

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

  • 14C-CORT125281Drug

    14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C

Study groups in NCT03877952
Study groupRoleWhat they receive
Study ParticipantsExperimentalOn Day 1, participants will receive a single oral dose of 14C-CORT125281 360 mg (6 X 60 mg capsules) after an overnight fast.
Receives: Drug: 14C-CORT125281

What is being measured

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

  1. Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281

    Measured: Until the mass balance criteria for all participants have been met (estimated up to 10 days)

Secondary outcomes (15)

  1. Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281

    Measured: Until the mass balance criteria for all participants have been met (estimated up to 10 days)

  2. Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281

    Measured: Until the mass balance criteria for all participants have been met (estimated up to 10 days)

  3. Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  4. Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (tmax)

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  5. 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)

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  6. Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2)

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  7. Plasma PK of Total Radioactivity after Oral Dosing: Mean Residence Time (MRT)

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  8. Plasma PK of CORT125281 after Oral Dosing: Cmax

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  9. Plasma PK of CORT125281 after Oral Dosing: tmax

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  10. Plasma PK of CORT125281 after Oral Dosing: AUC0-last

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  11. Plasma PK of CORT125281 after Oral Dosing: t1/2

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  12. Plasma PK of CORT125281 after Oral Dosing: MRT

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  13. Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing

    Measured: Pre-dose and at pre-specified time points up to Day 8 after dosing

  14. Number of CORT125281 Metabolites Accounting for ≥10% of Total Radioactivity Detected in Plasma, Urine, and Feces

    Measured: Until the mass balance criteria for all participants have been met (estimated up to 10 days)

  15. Percentage of Participants with One or More Adverse Events

    Measured: Until the mass balance criteria for all participants have been met (estimated up to 10 days)

Timeline

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

  1. First posted18 Mar 2019
  2. Study start13 Sep 2018
  3. Primary completion1 Nov 2018
  4. Study completion2 Nov 2018

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03877952
Sponsor's protocol ID
CORT125281-602
Other IDs
2018-001700-11, 2018
Status last verified
Mar 2019
First submitted
14 Mar 2019
Last updated
18 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 14C-CORT125281 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 5 inclusion and 12 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 18 Mar 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?

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)). 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 NCT03877952.

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 18 Mar 2019.

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