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

• Status: Recruiting
• Trial end date: 2023-02-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Fluvoxamine

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.