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

NCT ID: NCT05712265

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2023-02-23

Brief 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Miricorilant - Fluvoxamine/Miricorilant

Participants will receive a single oral dose of miricorilant 600 mg on Days 1 and 10 and a single oral dose of fluvoxamine 50 mg on Days 4 to 12.

Group Type: EXPERIMENTAL

Miricorilant

Intervention Type: DRUG

Miricorilant 6 x 100 mg coated tablets

Fluvoxamine

Intervention Type: DRUG

Fluvoxamine 50 mg tablet

Interventions

Miricorilant

Miricorilant 6 x 100 mg coated tablets

Intervention Type: DRUG

Fluvoxamine

Fluvoxamine 50 mg tablet

Intervention Type: DRUG

Other Intervention Names

CORT118335

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Custodio, PhD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

Site 01

Miami, Florida, United States

Countries

United States

Other Identifiers

CORT118335-856

Identifier Type: -

Identifier Source: org_study_id