Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04672499
- Lead Sponsor
- Corcept Therapeutics
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Body mass index (BMI) of 18.0 to 30.0 kg/m^2
- Must agree to adhere to the contraception requirements
- Additional criteria apply.
Exclusion Criteria
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1: Miricorilant 300 mg (Regimen A2) Miricorilant 150 mg tablets 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. Cohort 1: Miricorilant 900 mg (Regimen A1) Miricorilant 300 mg tablets 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. Cohort 2: Miricorilant (Regimen B1 and B2) Miricorilant 150 mg tablets 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. Cohort 2: Placebo (Regimen B1 and B2) Placebo 150 mg tablets 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. Cohort 3: Miricorilant (Regimen C1 and C2) Miricorilant 150 mg tablets 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. Cohort 3: Placebo (Regimen C1 and C2) Placebo 150 mg tablets 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with One or More Adverse Events 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 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 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 Outcome Measures
Name Time Method Plasma PK of Miricorilant: Time from Dosing at which Cmax was Apparent (Tmax) 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) 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 Pharmacokinetics (PK) of Miricorilant: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag) 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) 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) 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) Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17)
Trial Locations
- Locations (1)
Quotient Sciences
🇬🇧Ruddington, Nottingham, United Kingdom