Clinical trial NCT04990310: Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-08-04
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 \[14C\]-CORT113176 in healthy male participants.


Eligibility criteria: 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.

Primary outcomes:
measure: Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Secondary outcomes:
measure: Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
measure: Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
measure: Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
measure: Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)
timeFrame: Before dosing 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: Before dosing 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: Before dosing 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: Before dosing and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT113176 after Oral Dosing: Cmax
timeFrame: Before dosing and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT113176 after Oral Dosing: Tmax
timeFrame: Before dosing and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT113176 after Oral Dosing: AUC0-last
timeFrame: Before dosing and at pre-specified time points up to Day 8 after dosing
measure: Plasma PK of CORT113176 after Oral Dosing: t1/2
timeFrame: Before dosing 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: Before dosing and at pre-specified time points up to Day 8 after dosing
measure: Number of Participants with One or More Adverse Events
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Site 01
state: Nottingham
Study officials:
affiliation: Corcept Therapeutics
name: Hazel Hunt, Ph.D.
role: STUDY_DIRECTOR
References: