Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants
NCT ID: NCT04672499
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2020-04-27
2020-09-07
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: Miricorilant 900 mg (Regimen A1)
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.
Miricorilant 300 mg tablets
Miricorilant 300 mg tablets for oral administration
Cohort 1: Miricorilant 300 mg (Regimen A2)
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.
Miricorilant 150 mg tablets
Miricorilant 150 mg tablets for oral administration
Cohort 2: Miricorilant (Regimen B1 and B2)
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.
Miricorilant 150 mg tablets
Miricorilant 150 mg tablets for oral administration
Cohort 2: Placebo (Regimen B1 and B2)
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.
Placebo 150 mg tablets
Placebo to match miricorilant 150 mg tablets for oral administration
Cohort 3: Miricorilant (Regimen C1 and C2)
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.
Miricorilant 150 mg tablets
Miricorilant 150 mg tablets for oral administration
Cohort 3: Placebo (Regimen C1 and C2)
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.
Placebo 150 mg tablets
Placebo to match miricorilant 150 mg tablets for oral administration
Interventions
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Miricorilant 300 mg tablets
Miricorilant 300 mg tablets for oral administration
Miricorilant 150 mg tablets
Miricorilant 150 mg tablets for oral administration
Placebo 150 mg tablets
Placebo to match miricorilant 150 mg tablets for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must agree to adhere to the contraception requirements
* Additional criteria apply.
Exclusion Criteria
* 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)
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Sharan Sidhu, MBChB, BAO, MRCS, MFPM
Role: PRINCIPAL_INVESTIGATOR
Quotient Sciences
Locations
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Quotient Sciences
Ruddington, Nottingham, United Kingdom
Countries
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Other Identifiers
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2019-004655-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CORT118335-853
Identifier Type: -
Identifier Source: org_study_id