HealthyPhase 1NCT04990310
Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male Participants
A Phase 1 study testing [14C]-CORT113176 in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-CORT113176
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2021to 20 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- [14C]-CORT113176
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-CORT113176Drug
[14C]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Experimental | On Day 1, participants will receive a single oral dose of [14C]-CORT113176 450 mg (3 X 150 mg lipid formulation capsules) in the fed state. Receives: Drug: [14C]-CORT113176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176
Measured: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Secondary outcomes (13)
Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176
Measured: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176
Measured: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces
Measured: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (Tmax)
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
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)
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2)
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: Cmax
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: Tmax
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: AUC0-last
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: t1/2
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing
Measured: Before dosing and at pre-specified time points up to Day 8 after dosing
Number of Participants with One or More Adverse Events
Measured: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start18 Aug 2021
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hazel Hunt, Ph.D., Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990310
- Sponsor's protocol ID
- CORT113176-651
- Other IDs
- 2021-002544-78
- Status last verified
- Nov 2021
- First submitted
- 27 Jul 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04990310
- Acronym / sponsor ID
- CORT113176-651
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Experimental | Drug: [14C]-CORT113176On Day 1, participants will receive a single oral dose of [14C]-CORT113176 450 mg (3 X 150 mg lipid formulation capsules) in the fed state. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-CORT113176[14C]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C. | Drug | Study Participants |
Primary outcome
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)
13 secondary outcomes
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)
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)
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)
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
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
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
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
Plasma PK of CORT113176 after Oral Dosing: Cmax
Time frame: Before dosing and at pre-specified time points up to Day 8 after dosing
Plasma PK of CORT113176 after Oral Dosing: Tmax
Time frame: Before dosing and at pre-specified time points up to Day 8 after dosing
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
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazel Hunt, Ph.D. study director
Corcept Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-CORT113176 in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.