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Completed

NCT Number: NCT03878264

Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

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.

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Key information

Conditions

Age range

18 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

  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

CORT118335 Oral

Drug

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

Other names: Treatment A

14C-CORT118335 intravenous

Drug

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

Other names: Treatment B

14C-CORT118335 oral

Drug

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

Other names: Treatment C

Primary outcomes

  1. Absolute Oral Bioavailability (F) of CORT118335

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

  1. 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 15 after dosing

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

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

  6. PK of Plasma CORT118335 after Oral Dosing: Cmax

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

  7. PK of Plasma CORT118335 after Oral Dosing: Tmax

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

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

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

  9. PK of Plasma CORT118335 after Oral Dosing: MRT

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

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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

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

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

  23. Percentage of Participants with One or More Adverse Events

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

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2019
Registry last updated
Jun 11, 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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