Clinical trial NCT03877952: Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-03-18
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Secondary outcomes:
measure: Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
measure: Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
measure: Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (tmax)
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: 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)
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2)
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of Total Radioactivity after Oral Dosing: Mean Residence Time (MRT)
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT125281 after Oral Dosing: Cmax
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT125281 after Oral Dosing: tmax
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT125281 after Oral Dosing: AUC0-last
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT125281 after Oral Dosing: t1/2
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT125281 after Oral Dosing: MRT
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing
timeFrame: Pre-dose and at pre-specified time points up to Day 8 after dosing
measure: Number of CORT125281 Metabolites Accounting for ≥10% of Total Radioactivity Detected in Plasma, Urine, and Feces
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
measure: Percentage of Participants with One or More Adverse Events
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Quotient Sciences
name: Sharan Sidhu, MBChB, BAO, MRCS, MFPM
role: PRINCIPAL_INVESTIGATOR
References: