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

NCT05712265 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT118335-856
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration of miricorilant (Cmax)

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10

• Area under the curve from time zero to the time of last measurable plasma concentration of miricorilant (AUC0-last)

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10

• Area under the curve from time zero extrapolated to infinity of plasma concentration of miricorilant (AUC0-inf)

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10

Secondary Outcomes (4)

• Number of participants with one or more treatment-emergent adverse events (TEAEs)

  Up to 30 days after study drug administration

• Number of participants with one or more serious adverse events (SAEs)

  Up to 30 days after study drug administration

• Number of participants with a clinically-significant vital sign abnormality

  Up to Day 13

• Number of participants with a clinically-significant laboratory test abnormality

  Up to Day 13

Study Arms (1)

Miricorilant - Fluvoxamine/Miricorilant

EXPERIMENTAL

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.

Drug: Miricorilant; Drug: Fluvoxamine

Interventions

Miricorilant DRUG

Miricorilant 6 x 100 mg coated tablets

Also known as: CORT118335

Miricorilant - Fluvoxamine/Miricorilant

Fluvoxamine DRUG

Fluvoxamine 50 mg tablet

Miricorilant - Fluvoxamine/Miricorilant

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Site 01

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

CORT118335; Fluvoxamine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Officials

• Joseph Custodio, PhD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: January 24, 2023
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)