Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants

Corcept Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Miricorilant 300 mg tablets; Drug: Miricorilant 150 mg tablets; Drug: Placebo 150 mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT04672499

CORT118335-853

2019-004655-36 (EudraCT Number)

Details and patient eligibility

About

This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 6 patient groups, including a placebo group

Cohort 1: Miricorilant 900 mg (Regimen A1)

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant 300 mg tablets

Cohort 1: Miricorilant 300 mg (Regimen A2)

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant 150 mg tablets

Cohort 2: Miricorilant (Regimen B1 and B2)

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant 150 mg tablets

Cohort 2: Placebo (Regimen B1 and B2)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo 150 mg tablets

Cohort 3: Miricorilant (Regimen C1 and C2)

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant 150 mg tablets

Cohort 3: Placebo (Regimen C1 and C2)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo 150 mg tablets