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HealthyPhase 1NCT03878264

Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

A Phase 1 study testing CORT118335 Oral, 14C-CORT118335 intravenous and 14C-CORT118335 oral 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 absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures following a single oral dose of CORT118335 in healthy male participants. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
CORT118335 Oral, 14C-CORT118335 intravenous and 14C-CORT118335 oral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
6 Aug 2018to 24 Mar 2019
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 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 to 65 years of age for Part 1 and 30 to 65 years of age for Part 2
  • Body mass index of 18.0 to 30.0 kg/m^2
  • Provide written informed consent
  • Have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) for Part 2
  • Adhere to the contraception requirements.

Who cannot join

  • Have received any investigational medicine in a clinical research study within the previous 3 months or CORT118335 at any time
  • Employees or immediate family members of employees of the study site or Sponsor
  • Have a pregnant partner
  • 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 13Show 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, endocrine, metabolic, respiratory, neurological, or gastrointestinal disease
  • 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 past 3 months
  • Has consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
  • Are taking, or have taken, any prescribed, over-the-counter drug or vitamins/herbal remedies within 14 days (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: An Open-label, 2-part Study Designed to Assess the Absolute Bioavailability of CORT118335 and Determine the Mass Balance Recovery, Absorption, Metabolism and Elimination, and Metabolite Profile and Identification of Metabolite Structures of [14C]-CORT118335 in Healthy Male Subjects

This study will evaluate the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures following a single oral dose of CORT118335 in healthy male participants.

Conditions
Healthy
Being tested
CORT118335 Oral, 14C-CORT118335 intravenous, 14C-CORT118335 oral

What participants receive

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

  • CORT118335 OralDrug

    Also called Treatment A

    CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration

  • 14C-CORT118335 intravenousDrug

    Also called Treatment B

    14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C

  • 14C-CORT118335 oralDrug

    Also called Treatment C

    14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C

Study groups in NCT03878264
Study groupRoleWhat they receive
Part 1ExperimentalOn Day 1, participants will receive a single oral dose of CORT118335 900 mg (Treatment A) after an overnight fast, and a 15-minute intravenous infusion of a microdose of 14C-CORT118335 (Treatment B) beginning 2 hours 45 minutes after the oral dose is administered.
Receives: Drug: CORT118335 Oral; Drug: 14C-CORT118335 intravenous
Part 2ExperimentalOn Day 1, participants will receive a single oral dose of 14C-CORT118335 150 mg (Treatment C) after an overnight fast.
Receives: Drug: 14C-CORT118335 oral

What is being measured

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

  1. Absolute Oral Bioavailability (F) of CORT118335

    Measured: Predose and at pre-specified time points up to Day 12

  2. Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT118335

    Measured: Until the mass balance criteria have been met by all participants (estimated Day 17)

  3. Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT118335

    Measured: Until the mass balance criteria have been met by all participants (estimated Day 17)

  4. Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT118335

    Measured: Until the mass balance criteria have been met by all participants (estimated Day 17)

Secondary outcomes (23)

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

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

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

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

  3. 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 15 after dosing

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

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

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

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

  6. PK of Plasma CORT118335 after Oral Dosing: Cmax

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

  7. PK of Plasma CORT118335 after Oral Dosing: Tmax

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

  8. PK of Plasma CORT118335 after Oral Dosing: AUC0-last

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

  9. PK of Plasma CORT118335 after Oral Dosing: MRT

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

  10. PK of Plasma 14C-CORT118335 after IV Dosing: Cmax

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  11. PK of Plasma 14C-CORT118335 after IV Dosing: AUC0-last

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  12. PK of Plasma 14C-CORT118335 after IV Dosing: t1/2

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  13. PK of Plasma 14C-CORT118335 after IV Dosing: Total Clearance (CL)

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  14. PK of Plasma 14C-CORT118335 after IV Dosing: MRT

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  15. PK of Total Radioactivity in Plasma after IV Dosing: Cmax

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  16. PK of Total Radioactivity in Plasma after IV Dosing: AUC0-last

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  17. PK of Total Radioactivity in Plasma after IV Dosing: t1/2

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  18. PK of Total Radioactivity in Plasma after IV Dosing: CL

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  19. PK of Total Radioactivity in Plasma after IV Dosing: MRT

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

  20. PK in Plasma after IV Dosing: AUC0-last for 14C-CORT118335 / AUC0-last for Total Radioactivity

    Measured: Pre-dose and at pre-specified time points up to Day 12 after dosing

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

    Measured: Pre-dose and at pre-specified time points up to Day 15 after dosing

  22. Number of CORT118335 Metabolites Accounting for >10% of Total Radioactivity Detected in Plasma, Urine, and Feces

    Measured: Until the mass balance criteria have been met by all participants (estimated Day 17)

  23. Percentage of Participants with One or More Adverse Events

    Measured: Until the mass balance criteria have been met by all participants (estimated Day 17)

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 start6 Aug 2018
  3. Primary completion24 Mar 2019
  4. Study completion24 Mar 2019

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878264
Sponsor's protocol ID
CORT118335-851
Other IDs
2018-001507-36, 2018
Status last verified
Jun 2019
First submitted
14 Mar 2019
Last updated
11 Jun 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 CORT118335 Oral, 14C-CORT118335 intravenous and 14C-CORT118335 oral 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 13 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 11 Jun 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?

Absolute Oral Bioavailability (F) of CORT118335 (time frame: Predose and at pre-specified time points up to Day 12). The study lists 4 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 NCT03878264.

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 11 Jun 2019.

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