study to evaluate the effects of a cytochrome p450 2c19 inhibitor on the pharmacokinetics of miricorilant

Conditions: Antipsychotic Induced Weight Gain; Non-alcoholic Steatohepatitis (NASH)

Summary: 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.


Eligibility criteria:
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.