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OpenTrials
Completed

NCT Number: NCT03877952

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

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.

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Key information

Conditions

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

14C-CORT125281

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  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)

    Time frame: 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)

    Time frame: 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)

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

  8. Plasma PK of CORT125281 after Oral Dosing: Cmax

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

  9. Plasma PK of CORT125281 after Oral Dosing: tmax

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

  10. 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

  11. 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

  12. Plasma PK of CORT125281 after Oral Dosing: MRT

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2019
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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