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

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.

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.