HealthyPhase 1NCT05003713
Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants
A Phase 1 study testing CORT125236 and Prednisone in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.
Trial summary
This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to investigate whether CORT125236 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CORT125236 and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2021to 3 Feb 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 18.0 to 30.0 kg/m^2, inclusive
- Body weight ≤102 kg
- Willing to consume a high-fat breakfast, including pork
- Adheres to the contraception requirements of the protocol
- Additional criteria apply.
Who cannot join
- Received any investigational drug or device in a clinical research study within 90 days
- Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
- History of any drug or alcohol abuse in the past 2 years; a confirmed positive drugs of abuse test result
- Regular alcohol consumption; a confirmed positive alcohol breath test at screening
- Current smoker; a confirmed positive breath carbon monoxide reading; current user of e-cigarettes and nicotine replacement products in the last 6 months
- Female of childbearing potential, pregnant, or breastfeeding
Show all 17Show fewer
- Male participant with pregnant or lactating partners
- Clinically significant abnormal clinical chemistry, hematology or urinalysis result
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV)
- Active renal and/or hepatic disease
- History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), neurological or psychiatric disorder
- Any form of cancer in the 5 years (exceptions apply)
- History of adrenal insufficiency
- Have a condition that could be aggravated by glucocorticoid antagonism
- Donation or loss of greater than 400 mL of blood or plasma within the previous 3 months
- Currently using glucocorticoids or have a history of systemic glucocorticoid use in 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: A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125236 in Healthy Subjects, With an Optional Pharmacological Effects Cohort
This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to investigate whether CORT125236 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by the pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3 can be made at any point after completion of 3 SAD levels, and will be based on achieving sufficiently high plasma CORT125236 exposure in Part 1 of the study.
- Conditions
- Healthy
- Being tested
- CORT125236, Placebo matching CORT125236, Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORT125236Drug
CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration
Placebo matching CORT125236Drug
Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration
PrednisoneDrug
Prednisone tablet 25 mg (20 mg + 5 mg tablets) for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SAD Cohorts A through F CORT125236 | Experimental | Cohorts will receive a single dose of CORT125236 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. Cohort A will receive a 20-mg dose in a fasted state. Cohort B will receive a ≤3-fold increase in dose from Cohort A in a fasted state; the dose level and dose regimen (whether to split the dose) will be determined after evaluation of safety and PK data for Cohort A. Subsequent cohorts will receive a ≤3-fold increase in CORT125236 dose from the previous cohort in a fasted or fed state; the dose level, dose regimen, and prandial state will be determined after evaluation of safety and PK data from previous cohorts. Receives: Drug: CORT125236 |
| Part 1: SAD Cohorts A through F Placebo | Placebo comparator | Cohorts will receive a single dose of placebo matching CORT125236 lipid capsule formulation by mouth on Day 1. The dose regimen and prandial state will be the same as those for the cohort members receiving CORT125236. Receives: Drug: Placebo matching CORT125236 |
| Part 2: MAD Cohorts A through D CORT125236 | Experimental | Cohorts will receive once- or twice-daily doses of CORT125236 lipid capsule formulation by mouth for 14 days. The anticipated exposure will not exceed the highest exposure considered safe and well-tolerated during Part 1. The dose level, dose schedule, and prandial state for each cohort will be determined after evaluation of safety and PK data from Part 1 and preceding Part 2 cohorts. Receives: Drug: CORT125236 |
| Part 2: MAD Cohorts A through D Placebo | Placebo comparator | Cohorts will receive once- or twice-daily doses of placebo matching CORT125236 lipid capsule formulation by mouth for 14 days. The dose regimen and prandial state will be the same as those for the cohort members receiving CORT125236. Receives: Drug: Placebo matching CORT125236 |
| Part 3: Single Dose Pharmacodynamic Effect | Experimental | In Period 1, participants will receive a single dose of prednisone 25 mg (20 mg + 5 mg) tablet by mouth on Day 1 in a fasted or fed state. After a 7-day washout, in Period 2, participants will receive a single dose of prednisone as in Period 1 plus a single dose of CORT125236 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. The dose of CORT125236 and the prandial state will be determined after evaluation of safety and PK data from Part 1. Part 3 of the study is optional. Receives: Drug: CORT125236; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Events
Measured: Part 1 SAD Cohorts: up to Day 12; Part 2 MAD Cohorts: up to Day 25; Part 3 Cohort: up to Day 19
Secondary outcomes (14)
Maximum Plasma Concentration (Cmax) of CORT125236
Measured: Before dosing and at pre-specified time points up to Day 5 (Part 1 SAD Cohorts), or up to Day 18 (Part 2 MAD Cohorts)
Time of Cmax (Tmax) of Plasma CORT125236
Measured: Before dosing and at pre-specified time points up to Day 5 (Part 1 SAD Cohorts), or up to Day 18 (Part 2 MAD Cohorts)
Apparent Elimination Half-life (t1/2) of Plasma CORT125236
Measured: Before dosing and at pre-specified time points up to Day 5 (Part 1 SAD Cohorts), or up to Day 18 (Part 2 MAD Cohorts)
Area Under the Plasma Concentration-time Curve (AUC) of CORT125236
Measured: Before dosing and at pre-specified time points up to Day 5 (Part 1 SAD Cohorts), or up to Day 18 (Part 2 MAD Cohorts)
Serum Cortisol Concentration
Measured: Before dosing on Days 1 and 14 (Part 2 MAD Cohorts)
Plasma Adrenocorticotropic Hormone (ACTH) Concentration
Measured: Before dosing on Days 1 and 14 (Part 2 MAD Cohorts)
Eosinophil Count
Measured: Before dosing and at pre-specified time points up to 24 hours after dosing (Part 3, Periods 1 and 2 PD Cohort)
Lymphocyte Count
Measured: Before dosing and at pre-specified time points up to 24 hours after dosing (Part 3, Period 1 and 2 PD Cohort)
Neutrophil Count
Measured: Before dosing and at pre-specified time points up to 24 hours after dosing (Part 3, Period 1 and 2 PD Cohort)
Serum Osteocalcin Concentration
Measured: Before dosing and at pre-specified time points up to 24 hours after dosing (Part 3, Period 1 and 2 PD Cohort)
Plasma Glucose
Measured: 4 hours after dosing and immediately prior to a high-carbohydrate lunch, and approximately 2 hours after starting the lunch (Part 3, Period 1 and 2 PD Cohort)
Serum Insulin
Measured: 4 hours after dosing and immediately prior to a high-carbohydrate lunch, and approximately 2 hours after starting the lunch (Part 3, Period 1 and 2 PD Cohort)
Plasma Tumor Necrosis Factor Alpha (TNF-α) Concentration following ex vivo Lipopolysaccharide (LPS) Stimulation
Measured: Before dosing and 1, 2, and 4 hours after dosing (Part 3, Periods 1 and 2 PD Cohort)
Plasma Interleukin-1 Beta (IL-1β) Concentration following ex vivo LPS Stimulation
Measured: Before dosing and 1, 2, and 4 hours after dosing (Part 3, Periods 1 and 2 PD Cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start3 Aug 2021
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 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
- NCT05003713
- Sponsor's protocol ID
- CORT125236-150
- Other IDs
- 2021-001407-32
- Status last verified
- Mar 2023
- First submitted
- 26 Jul 2021
- Last updated
- 22 Mar 2023
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125236 in Healthy Subjects, With an Optional Pharmacological Effects Cohort
- ClinicalTrials.gov ID
- NCT05003713
- Acronym / sponsor ID
- CORT125236-150
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 12 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 is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to investigate whether CORT125236 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by the pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3 can be made at any point after completion of 3 SAD levels, and will be based on achieving sufficiently high plasma CORT125236 exposure in Part 1 of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: SAD Cohorts A through F CORT125236 | Experimental | Drug: CORT125236Cohorts will receive a single dose of CORT125236 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. Cohort A will receive a 20-mg dose in a fasted state. Cohort B will receive a ≤3-fold increase in dose from Cohort A in a fasted state; the dose level and dose regimen (whether to split the dose) will be determined after evaluation of safety and PK data for Cohort A. Subsequent cohorts will receive a ≤3-fold increase in CORT125236 dose from the previous cohort in a fasted or fed state; the dose level, dose regimen, and prandial state will be determined after evaluation of safety and PK data from previous cohorts. |
| Part 1: SAD Cohorts A through F Placebo | Placebo comparator | Drug: Placebo matching CORT125236Cohorts will receive a single dose of placebo matching CORT125236 lipid capsule formulation by mouth on Day 1. The dose regimen and prandial state will be the same as those for the cohort members receiving CORT125236. |
| Part 2: MAD Cohorts A through D CORT125236 | Experimental | Drug: CORT125236Cohorts will receive once- or twice-daily doses of CORT125236 lipid capsule formulation by mouth for 14 days. The anticipated exposure will not exceed the highest exposure considered safe and well-tolerated during Part 1. The dose level, dose schedule, and prandial state for each cohort will be determined after evaluation of safety and PK data from Part 1 and preceding Part 2 cohorts. |
| Part 2: MAD Cohorts A through D Placebo | Placebo comparator | Drug: Placebo matching CORT125236Cohorts will receive once- or twice-daily doses of placebo matching CORT125236 lipid capsule formulation by mouth for 14 days. The dose regimen and prandial state will be the same as those for the cohort members receiving CORT125236. |
| Part 3: Single Dose Pharmacodynamic Effect | Experimental | Drug: CORT125236, Drug: PrednisoneIn Period 1, participants will receive a single dose of prednisone 25 mg (20 mg + 5 mg) tablet by mouth on Day 1 in a fasted or fed state. After a 7-day washout, in Period 2, participants will receive a single dose of prednisone as in Period 1 plus a single dose of CORT125236 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. The dose of CORT125236 and the prandial state will be determined after evaluation of safety and PK data from Part 1. Part 3 of the study is optional. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index 18.0 to 30.0 kg/m^2, inclusive
- Body weight ≤102 kg
- Willing to consume a high-fat breakfast, including pork
- Adheres to the contraception requirements of the protocol
- Additional criteria apply.
Key exclusion criteria (17 listed)
- Received any investigational drug or device in a clinical research study within 90 days
- Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
- History of any drug or alcohol abuse in the past 2 years; a confirmed positive drugs of abuse test result
- Regular alcohol consumption; a confirmed positive alcohol breath test at screening
- Current smoker; a confirmed positive breath carbon monoxide reading; current user of e-cigarettes and nicotine replacement products in 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 |
|---|---|---|
| CORT125236CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration | Drug | Part 1: SAD Cohorts A through F CORT125236, Part 2: MAD Cohorts A through D CORT125236, Part 3: Single Dose Pharmacodynamic Effect |
| Placebo matching CORT125236Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration | Drug | Part 1: SAD Cohorts A through F Placebo, Part 2: MAD Cohorts A through D Placebo |
| PrednisonePrednisone tablet 25 mg (20 mg + 5 mg tablets) for oral administration | Drug | Part 3: Single Dose Pharmacodynamic Effect |
Primary outcome
Number of Participants with One or More Adverse Events
Time frame: Part 1 SAD Cohorts: up to Day 12; Part 2 MAD Cohorts: up to Day 25; Part 3 Cohort: up to Day 19
14 secondary outcomes
Maximum Plasma Concentration (Cmax) of CORT125236
Time frame: Before dosing and at pre-specified time points up to Day 5 (Part 1 SAD Cohorts), or up to Day 18 (Part 2 MAD Cohorts)
Time of Cmax (Tmax) of Plasma CORT125236
Time frame: Before dosing and at pre-specified time points up to Day 5 (Part 1 SAD Cohorts), or up to Day 18 (Part 2 MAD Cohorts)
Apparent Elimination Half-life (t1/2) of Plasma CORT125236
Time frame: Before dosing and at pre-specified time points up to Day 5 (Part 1 SAD Cohorts), or up to Day 18 (Part 2 MAD Cohorts)
Area Under the Plasma Concentration-time Curve (AUC) of CORT125236
Time frame: Before dosing and at pre-specified time points up to Day 5 (Part 1 SAD Cohorts), or up to Day 18 (Part 2 MAD Cohorts)
Serum Cortisol Concentration
Time frame: Before dosing on Days 1 and 14 (Part 2 MAD Cohorts)
Plasma Adrenocorticotropic Hormone (ACTH) Concentration
Time frame: Before dosing on Days 1 and 14 (Part 2 MAD Cohorts)
Eosinophil Count
Time frame: Before dosing and at pre-specified time points up to 24 hours after dosing (Part 3, Periods 1 and 2 PD Cohort)
Lymphocyte Count
Time frame: Before dosing and at pre-specified time points up to 24 hours after dosing (Part 3, Period 1 and 2 PD Cohort)
Neutrophil Count
Time frame: Before dosing and at pre-specified time points up to 24 hours after dosing (Part 3, Period 1 and 2 PD Cohort)
Serum Osteocalcin Concentration
Time frame: Before dosing and at pre-specified time points up to 24 hours after dosing (Part 3, Period 1 and 2 PD Cohort)
Plasma Glucose
Time frame: 4 hours after dosing and immediately prior to a high-carbohydrate lunch, and approximately 2 hours after starting the lunch (Part 3, Period 1 and 2 PD Cohort)
Serum Insulin
Time frame: 4 hours after dosing and immediately prior to a high-carbohydrate lunch, and approximately 2 hours after starting the lunch (Part 3, Period 1 and 2 PD Cohort)
Plasma Tumor Necrosis Factor Alpha (TNF-α) Concentration following ex vivo Lipopolysaccharide (LPS) Stimulation
Time frame: Before dosing and 1, 2, and 4 hours after dosing (Part 3, Periods 1 and 2 PD Cohort)
Plasma Interleukin-1 Beta (IL-1β) Concentration following ex vivo LPS Stimulation
Time frame: Before dosing and 1, 2, and 4 hours after dosing (Part 3, Periods 1 and 2 PD Cohort)
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 22 Mar 2023.
- Individual participant dataSharing planned: No
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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 CORT125236 and Prednisone 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 17 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 22 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with One or More Adverse Events (time frame: Part 1 SAD Cohorts: up to Day 12; Part 2 MAD Cohorts: up to Day 25; Part 3 Cohort: up to Day 19). 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 22 Mar 2023.