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

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.

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.