Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant

Inclusion criteria

• Able to understand a written informed consent
• Willing and able to comply with all study requirements including potential CYP 2C19 genotyping analysis
• Male participants must agree to use an adequate method of contraception
• Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential
• Body mass index of 19.0 to 32.0 kg/m^2
• Body weight ≥50 kg.

Exclusion criteria

• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Presence or history of clinically significant allergy requiring treatment. Hay fever is allowed unless it is active.
• Significant skin disease, including rash, food allergy, eczema, psoriasis, or urticaria
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (except cholecystectomy), bleeding disorder, neurological or psychiatric disorder, as judged by the Investigator
• Poor venous access that limits phlebotomy
• Evidence of current SARS-CoV-2 infection
• Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are allowed.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
• Evidence of renal impairment at screening
• Positive highly sensitive serum pregnancy test at screening or admission. Those who are pregnant or lactating will be excluded. A woman is considered of childbearing potential unless she is permanently sterile or is postmenopausal.
• Clinically-significant ECG abnormalities or vital sign abnormalities at screening or at baseline
• Have received any study drug in a clinical research study within 30 days (or 5 half-lives if longer) prior to first dose of study medication
• Are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 2 g per day acetaminophen or COVID-19 vaccines) in the 14 days before study drug administration. Exceptions may apply.
• Are currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months, or 3 months for inhaled products
• Are taking, or have taken, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors within 3 months before study drug administration
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in men >21 units per week and women >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine)
• Confirmed positive alcohol urine test at screening or admission
• Current smokers and those who have smoked within the last 12 months
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• Positive drugs of abuse test result
• Male participants with pregnant or lactating partners
• Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication
• Are, or are immediate family members of a study site or Sponsor employee
• Failure to satisfy the investigator of fitness to participate for any other reason.