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OpenTrials
Completed

NCT Number: NCT04990310

Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 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]-CORT113176 in healthy male 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

Site 01

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
  • Willing and able to participate in the whole study
  • Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
  • Provide written informed consent
  • Adhere to the contraception requirements.

Exclusion criteria

  • Have received any investigational medicine in a clinical research study within 90 days
  • Are, or are immediate family members of, a study site or sponsor employee
  • Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
  • History of any drug or alcohol abuse, or regularly consume >21 units alcohol per week
  • Current smoker or user of e-cigarettes and nicotine replacement products within the last 6 months
  • Have pregnant or lactating partners
  • Radiation exposure, exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
  • Clinically significant abnormal results of clinical chemistry, hematology or urinalysis as judged by the investigator
  • Confirmed positive drugs of abuse test result
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
  • Active renal and/or hepatic disease
  • History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
  • Any form of cancer within the last 5 years (exceptions apply)
  • History and/or symptoms of adrenal insufficiency
  • Condition that could be aggravated by glucocorticoid antagonism or activation
  • Donation of blood or plasma 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 herbal remedies (other than up to 4 g of paracetamol per day) within 14 days. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis.
  • Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
  • Additional criteria apply.

Treatment and study plan

[14C]-CORT113176

Drug

[14C]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.

Primary outcomes

  1. Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176

    Time frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)

Secondary outcomes

  1. Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176

    Time frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)

  2. Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176

    Time frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)

  3. Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces

    Time frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)

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

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

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

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

  6. 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: Before dosing and at pre-specified time points up to Day 8 after dosing

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

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

  8. Plasma PK of CORT113176 after Oral Dosing: Cmax

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

  9. Plasma PK of CORT113176 after Oral Dosing: Tmax

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

  10. Plasma PK of CORT113176 after Oral Dosing: AUC0-last

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

  11. Plasma PK of CORT113176 after Oral Dosing: t1/2

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

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

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

  13. Number of Participants with One or More Adverse Events

    Time frame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-CORT113176 in Healthy Male Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2021
Registry last updated
Nov 24, 2021

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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