HealthyPhase 1NCT04672499
Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants
A Phase 1 study testing Miricorilant 300 mg tablets and Miricorilant 150 mg tablets in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.
Trial summary
This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants. 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?
- Miricorilant 300 mg tablets and Miricorilant 150 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2020to 7 Sep 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) of 18.0 to 30.0 kg/m^2
- Must agree to adhere to the contraception requirements
- Additional criteria apply.
Who cannot join
- Received any investigational medicinal product in a clinical research study within the last 90 days
- Male participants who have pregnant or lactating partners
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption: a confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked or used e-cigarettes or nicotine replacement products within the last 6 months
- Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission)
Show all 20Show fewer
- Clinically significant abnormal clinical chemistry, haematology 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) results
- Active renal and/or hepatic disease
- History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, chronic respiratory, neurological or psychiatric disorder, as judged by the Investigator
- Any form of cancer within the last 2 years (exceptions apply)
- History and/or symptoms of adrenal insufficiency
- Regularly consumes liquorice or other glycyrrhetic acid derivatives
- History of clinically significant gastrointestinal disease
- Currently using glucocorticoids or have a history of systemic glucocorticoid use within the last 12 months or 3 months for inhaled products
- Presence or history of clinically significant allergy requiring treatment
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Taking, or have taken, any prescribed, over-the-counter drug (other than up to 4 g per day paracetamol) or vitamins/herbal remedies within 14 days. Exceptions may apply on a case by case basis
- 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 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Miricorilant Tablet Formulations Following Single and Multiple Oral Doses in Healthy Participants
This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.
Read the detailed description
Cohort 1 will evaluate safety, tolerability, and PK of single doses of a 150-mg and a new 300-mg tablet formulation of miricorilant. Cohort 1 treatment will be randomized and open label.
Optional Cohorts 2 and 3 will evaluate single- and repeated-dose administration of miricorilant using a formulation, dose, and dose-regimen determined after interim evaluation of PK and safety data from previous cohorts. Cohort 2 and 3 treatments will be randomized, blinded, and placebo controlled.
- Conditions
- Healthy
- Being tested
- Miricorilant 300 mg tablets, Miricorilant 150 mg tablets, Placebo 150 mg tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miricorilant 300 mg tabletsDrug
Also called CORT118335
Miricorilant 300 mg tablets for oral administration
Miricorilant 150 mg tabletsDrug
Also called CORT118335
Miricorilant 150 mg tablets for oral administration
Placebo 150 mg tabletsDrug
Placebo to match miricorilant 150 mg tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Miricorilant 900 mg (Regimen A1) | Experimental | Participants will receive a single oral dose of miricorilant 900 mg (3 X 300 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label. Receives: Drug: Miricorilant 300 mg tablets |
| Cohort 1: Miricorilant 300 mg (Regimen A2) | Experimental | Participants will receive a single oral dose of miricorilant 300 mg (2 X 150 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label. Receives: Drug: Miricorilant 150 mg tablets |
| Cohort 2: Miricorilant (Regimen B1 and B2) | Experimental | Participants will receive a single oral dose of miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded. Receives: Drug: Miricorilant 150 mg tablets |
| Cohort 2: Placebo (Regimen B1 and B2) | Placebo comparator | Participants will receive a single oral dose of placebo matching miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded. Receives: Drug: Placebo 150 mg tablets |
| Cohort 3: Miricorilant (Regimen C1 and C2) | Experimental | Participants will receive two oral doses (morning and evening) of miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded. Receives: Drug: Miricorilant 150 mg tablets |
| Cohort 3: Placebo (Regimen C1 and C2) | Placebo comparator | Participants will receive two oral doses (morning and evening) of placebo matching miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and placebo matching miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded. Receives: Drug: Placebo 150 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with One or More Adverse Events
Measured: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Percentage of Participants with One or More Serious Adverse Events
Measured: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Percentage of Participants Discontinued from the Study due to an Adverse Event
Measured: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Secondary outcomes (6)
Plasma Pharmacokinetics (PK) of Miricorilant: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag)
Measured: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
Plasma PK of Miricorilant: Maximum Observed Concentration (Cmax)
Measured: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Plasma PK of Miricorilant: Time from Dosing at which Cmax was Apparent (Tmax)
Measured: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Plasma PK of Miricorilant: Apparent Elimination Half-life (t1/2)
Measured: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Plasma PK of Miricorilant: Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-last)
Measured: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
Plasma PK of Miricorilant: Area Under the Curve from Time Zero to 24 Hours Postdose (AUC0-24)
Measured: Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start27 Apr 2020
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT04672499
- Sponsor's protocol ID
- CORT118335-853
- Other IDs
- 2019-004655-36, 2019
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Miricorilant Tablet Formulations Following Single and Multiple Oral Doses in Healthy Participants
- ClinicalTrials.gov ID
- NCT04672499
- Acronym / sponsor ID
- CORT118335-853
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 17 Dec 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 study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.
Detailed description
Cohort 1 will evaluate safety, tolerability, and PK of single doses of a 150-mg and a new 300-mg tablet formulation of miricorilant. Cohort 1 treatment will be randomized and open label.
Optional Cohorts 2 and 3 will evaluate single- and repeated-dose administration of miricorilant using a formulation, dose, and dose-regimen determined after interim evaluation of PK and safety data from previous cohorts. Cohort 2 and 3 treatments will be randomized, blinded, and placebo controlled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Miricorilant 900 mg (Regimen A1) | Experimental | Drug: Miricorilant 300 mg tabletsParticipants will receive a single oral dose of miricorilant 900 mg (3 X 300 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label. |
| Cohort 1: Miricorilant 300 mg (Regimen A2) | Experimental | Drug: Miricorilant 150 mg tabletsParticipants will receive a single oral dose of miricorilant 300 mg (2 X 150 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label. |
| Cohort 2: Miricorilant (Regimen B1 and B2) | Experimental | Drug: Miricorilant 150 mg tabletsParticipants will receive a single oral dose of miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded. |
| Cohort 2: Placebo (Regimen B1 and B2) | Placebo comparator | Drug: Placebo 150 mg tabletsParticipants will receive a single oral dose of placebo matching miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded. |
| Cohort 3: Miricorilant (Regimen C1 and C2) | Experimental | Drug: Miricorilant 150 mg tabletsParticipants will receive two oral doses (morning and evening) of miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded. |
| Cohort 3: Placebo (Regimen C1 and C2) | Placebo comparator | Drug: Placebo 150 mg tabletsParticipants will receive two oral doses (morning and evening) of placebo matching miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and placebo matching miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) of 18.0 to 30.0 kg/m^2
- Must agree to adhere to the contraception requirements
- Additional criteria apply.
Key exclusion criteria (20 listed)
- Received any investigational medicinal product in a clinical research study within the last 90 days
- Male participants who have pregnant or lactating partners
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption: a confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked or used e-cigarettes or 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 |
|---|---|---|
| Miricorilant 300 mg tabletsAlso: CORT118335Miricorilant 300 mg tablets for oral administration | Drug | Cohort 1: Miricorilant 900 mg (Regimen A1) |
| Miricorilant 150 mg tabletsAlso: CORT118335Miricorilant 150 mg tablets for oral administration | Drug | Cohort 1: Miricorilant 300 mg (Regimen A2), Cohort 2: Miricorilant (Regimen B1 and B2), Cohort 3: Miricorilant (Regimen C1 and C2) |
| Placebo 150 mg tabletsPlacebo to match miricorilant 150 mg tablets for oral administration | Drug | Cohort 2: Placebo (Regimen B1 and B2), Cohort 3: Placebo (Regimen C1 and C2) |
Primary outcome
Percentage of Participants with One or More Adverse Events
Time frame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Percentage of Participants with One or More Serious Adverse Events
Time frame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
Percentage of Participants Discontinued from the Study due to an Adverse Event
Time frame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)
6 secondary outcomes
Plasma Pharmacokinetics (PK) of Miricorilant: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
Plasma PK of Miricorilant: Maximum Observed Concentration (Cmax)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Plasma PK of Miricorilant: Time from Dosing at which Cmax was Apparent (Tmax)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Plasma PK of Miricorilant: Apparent Elimination Half-life (t1/2)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Plasma PK of Miricorilant: Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-last)
Time frame: Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4)
Plasma PK of Miricorilant: Area Under the Curve from Time Zero to 24 Hours Postdose (AUC0-24)
Time frame: Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
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 17 Dec 2020.
- 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.
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 Miricorilant 300 mg tablets and Miricorilant 150 mg tablets 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 3 inclusion and 20 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 17 Dec 2020. 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?
Percentage of Participants with One or More Adverse Events (time frame: Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3)). The study lists 3 primary outcomes in all. 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 17 Dec 2020.