A Phase 1, Open-Label, Fixed-Sequence Crossover Study to Evaluate the Effect of a Strong Inhibitor of Cytochrome P450 2C19 on the Pharmacokinetics of Miricorilant in Healthy Subjects

CORT118335-856

The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 \[(CYP) 2C19\] inhibitor, fluvoxamine, in healthy participants. Participants will receive a single dose of miricorilant under fed conditions with a standard breakfast after an overnight fast alone and in combination with once-daily doses of fluvoxamine. Blood samples will be collected at regular intervals for PK and safety analysis between admission and discharge from the clinical unit.

2023-01-24

2023-02-23

2023-02-23

Completed

Early phase I

26

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

2023-03-22