Healthy AdultsPhase 1NCT04249323
Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants
A Phase 1 study testing CORT113176 Lipid Capsule Formulation and Prednisone in people with Healthy Adults, 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 CORT113176 in healthy participants; Part 3 is an optional part to investigate whether CORT113176 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 Adults
- What is being tested?
- CORT113176 Lipid Capsule Formulation and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jan 2020to 15 Oct 2020
- 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 (BMI) 18.0 to 30.0 kg/m^2, inclusive
- Body weight ≤102 kg
- Willing to consume a high-fat breakfast, including pork
- Agrees to adhere 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 the last 90 days
- History of any drug or alcohol abuse in the last 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 or nicotine replacement products in the last 6 months
- Female of childbearing potential, pregnant or breastfeeding
- Have a pregnant partner
Show all 15Show fewer
- 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 or hepatic disease
- History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal, neurological, or psychiatric disorder
- Any form of cancer in the last 5 years (exceptions apply)
- History of adrenal insufficiency
- Have a condition that could be aggravated by glucocorticoid and/or mineralocorticoid blockade
- Currently using glucocorticoids or 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.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT113176 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 CORT113176 in healthy participants; Part 3 is an optional part to investigate whether CORT113176 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 pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The expected exposure for the daily MAD level at steady state (taking into consideration potential accumulation on repeat dosing) must not exceed the highest exposure considered to be safe and well tolerated during preceding SAD cohorts.
- Conditions
- Healthy Adults
- Being tested
- CORT113176 Lipid Capsule Formulation, Placebo matching CORT113176 Lipid Capsule Formulation, Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORT113176 Lipid Capsule FormulationDrug
CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
Placebo matching CORT113176 Lipid Capsule FormulationDrug
Placebo matching CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
PrednisoneDrug
Prednisone standard release tablets 1 x 20 mg plus 1 x 5 mg for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SAD Cohorts A through H CORT113176 | Experimental | Cohorts will receive a single dose of CORT113176 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. Cohort A will receive a 50-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 will be determined after evaluation of safety and PK data for Cohort A. Subsequent cohorts will receive a ≤3-fold increase in CORT113176 dose from the previous cohort in a fasted or fed state; the dose and prandial state will be determined after evaluation of safety and PK data from previous cohorts. Following interim review of PK data, an alternative lipidic formulation may be administered beginning with Cohort B. Receives: Drug: CORT113176 Lipid Capsule Formulation |
| Part 1: SAD Cohorts A through H Placebo | Placebo comparator | Cohorts will receive a single dose of placebo matching CORT113176 lipid capsule formulation by mouth on Day 1. The dose of placebo, prandial state, and choice of formulation will match that used for the corresponding SAD cohorts receiving CORT113176. Receives: Drug: Placebo matching CORT113176 Lipid Capsule Formulation |
| Part 2: MAD Cohorts A through D CORT113176 | Experimental | Cohorts will receive once- or twice-daily doses of CORT113176 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 schedule and prandial state will be determined after evaluation of safety and PK data from Part 1. The choice of formulation of CORT113176 to be used in Part 2 will depend on data review for Part 1. Receives: Drug: CORT113176 Lipid Capsule Formulation |
| Part 2: MAD Cohorts A through D Placebo | Placebo comparator | Cohorts will receive once- or twice-daily doses of placebo matching CORT113176 lipid capsule formulation by mouth for 14 days. The dose of placebo, prandial state, and choice of formulation will match that used for the corresponding MAD cohorts receiving CORT113176. Receives: Drug: Placebo matching CORT113176 Lipid Capsule Formulation |
| Part 3: Single Dose Pharmacodynamic Effect | Experimental | In Period 1, participants will receive a single dose of prednisone 25 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 CORT113176 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. The dose of CORT113176 and the prandial state will be determined after evaluation of safety and PK data from Part 1. The choice of formulation of CORT113176 to be used in Part 3 will depend on data review for Part 1. Part 3 will proceed only if sufficiently high plasma CORT113176 exposure is achieved in Part 1. Receives: Drug: CORT113176 Lipid Capsule Formulation; 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 9; Part 2 MAD Cohorts: up to Day 23; Part 3 Cohort: up to Day 19
Secondary outcomes (6)
Maximum Plasma Concentration (Cmax) of CORT113176
Measured: Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Time of Cmax (Tmax) of CORT113176
Measured: Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Apparent Elimination Half-life (t1/2) of Plasma CORT113176
Measured: Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Area Under the Plasma Concentration-time Curve (AUC) of CORT113176
Measured: Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Serum Cortisol
Measured: Predose on Days 1 and 14 (Part 2 MAD Cohorts)
Serum Adrenocorticotropic Hormone (ACTH)
Measured: Predose on Days 1 and 14 (Part 2 MAD Cohorts)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start27 Jan 2020
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChb, BAO, MRCS, MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249323
- Sponsor's protocol ID
- CORT113176-650
- Other IDs
- 2019-004258-27, 2019
- Status last verified
- Jan 2022
- First submitted
- 29 Jan 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT113176 in Healthy Subjects, With an Optional Pharmacological Effects Cohort
- ClinicalTrials.gov ID
- NCT04249323
- Acronym / sponsor ID
- CORT113176-650
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 30 Jan 2020 (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 CORT113176 in healthy participants; Part 3 is an optional part to investigate whether CORT113176 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 pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The expected exposure for the daily MAD level at steady state (taking into consideration potential accumulation on repeat dosing) must not exceed the highest exposure considered to be safe and well tolerated during preceding SAD cohorts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: SAD Cohorts A through H CORT113176 | Experimental | Drug: CORT113176 Lipid Capsule FormulationCohorts will receive a single dose of CORT113176 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. Cohort A will receive a 50-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 will be determined after evaluation of safety and PK data for Cohort A. Subsequent cohorts will receive a ≤3-fold increase in CORT113176 dose from the previous cohort in a fasted or fed state; the dose and prandial state will be determined after evaluation of safety and PK data from previous cohorts. Following interim review of PK data, an alternative lipidic formulation may be administered beginning with Cohort B. |
| Part 1: SAD Cohorts A through H Placebo | Placebo comparator | Drug: Placebo matching CORT113176 Lipid Capsule FormulationCohorts will receive a single dose of placebo matching CORT113176 lipid capsule formulation by mouth on Day 1. The dose of placebo, prandial state, and choice of formulation will match that used for the corresponding SAD cohorts receiving CORT113176. |
| Part 2: MAD Cohorts A through D CORT113176 | Experimental | Drug: CORT113176 Lipid Capsule FormulationCohorts will receive once- or twice-daily doses of CORT113176 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 schedule and prandial state will be determined after evaluation of safety and PK data from Part 1. The choice of formulation of CORT113176 to be used in Part 2 will depend on data review for Part 1. |
| Part 2: MAD Cohorts A through D Placebo | Placebo comparator | Drug: Placebo matching CORT113176 Lipid Capsule FormulationCohorts will receive once- or twice-daily doses of placebo matching CORT113176 lipid capsule formulation by mouth for 14 days. The dose of placebo, prandial state, and choice of formulation will match that used for the corresponding MAD cohorts receiving CORT113176. |
| Part 3: Single Dose Pharmacodynamic Effect | Experimental | Drug: CORT113176 Lipid Capsule Formulation, Drug: PrednisoneIn Period 1, participants will receive a single dose of prednisone 25 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 CORT113176 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. The dose of CORT113176 and the prandial state will be determined after evaluation of safety and PK data from Part 1. The choice of formulation of CORT113176 to be used in Part 3 will depend on data review for Part 1. Part 3 will proceed only if sufficiently high plasma CORT113176 exposure is achieved in Part 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) 18.0 to 30.0 kg/m^2, inclusive
- Body weight ≤102 kg
- Willing to consume a high-fat breakfast, including pork
- Agrees to adhere to the contraception requirements of the protocol
- Additional criteria apply.
Key exclusion criteria (15 listed)
- Received any investigational drug or device in a clinical research study within the last 90 days
- History of any drug or alcohol abuse in the last 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 or nicotine replacement products in the last 6 months
- Female of childbearing potential, pregnant or breastfeeding
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 |
|---|---|---|
| CORT113176 Lipid Capsule FormulationCORT113176 Lipid Capsule Formulation 10-200 mg for oral administration | Drug | Part 1: SAD Cohorts A through H CORT113176, Part 2: MAD Cohorts A through D CORT113176, Part 3: Single Dose Pharmacodynamic Effect |
| Placebo matching CORT113176 Lipid Capsule FormulationPlacebo matching CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration | Drug | Part 1: SAD Cohorts A through H Placebo, Part 2: MAD Cohorts A through D Placebo |
| PrednisonePrednisone standard release tablets 1 x 20 mg plus 1 x 5 mg 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 9; Part 2 MAD Cohorts: up to Day 23; Part 3 Cohort: up to Day 19
6 secondary outcomes
Maximum Plasma Concentration (Cmax) of CORT113176
Time frame: Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Time of Cmax (Tmax) of CORT113176
Time frame: Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Apparent Elimination Half-life (t1/2) of Plasma CORT113176
Time frame: Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Area Under the Plasma Concentration-time Curve (AUC) of CORT113176
Time frame: Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Serum Cortisol
Time frame: Predose on Days 1 and 14 (Part 2 MAD Cohorts)
Serum Adrenocorticotropic Hormone (ACTH)
Time frame: Predose on Days 1 and 14 (Part 2 MAD Cohorts)
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 1 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Sharan Sidhu, MBChb, BAO, MRCS, MFPM principal investigator
Quotient Sciences
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 CORT113176 Lipid Capsule Formulation and Prednisone in people with Healthy Adults, 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 15 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 1 Feb 2022. 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 9; Part 2 MAD Cohorts: up to Day 23; 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 1 Feb 2022.