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

Corcept Therapeutics

Status and phase

Completed

Phase 1

Conditions

Antipsychotic Induced Weight Gain

Non-alcoholic Steatohepatitis (NASH)

Treatments

Drug: Miricorilant

Drug: Fluvoxamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05712265

CORT118335-856

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.