Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.

Key facts

Study ID

NCT07240116

Run by

Corcept Therapeutics

People needed

18

Starts

2025-09-11

Expected to finish

2026-03-03

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand written informed consent
• Willing and able to comply with study requirements
• Willing to comply with protocol-specified contraception requirements
• Healthy male or non-pregnant, non-lactating female of non-childbearing potential per Investigator assessment.
• Body mass index (BMI) of 18.0 to 30.0 kg/m\^2 at screening
• Weight of at least 50 kg at screening

You may not qualify if…

• Serious adverse reaction or hypersensitivity to any drug or formulation excipients
• History of clinically significant allergy requiring treatment
• History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
• Any form of cancer within the 5 years before the first does of this study
• History and/or symptoms of adrenal insufficiency
• History of clinically significant GI disease
• Condition or history of a condition that could be aggravated by glucocorticoid antagonism or glucocorticoid activation
• History of additional risk factors for torsades de pointes
• Poor venous access that limits phlebotomy
• Clinically significant abnormal clinical chemistry, hematology or urinalysis
• History or evidence of hypokalemia
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
• Evidence of renal impairment at screening
• Positive serum or highly sensitive urine pregnancy test at screening or first admission
• Clinically significant ECG abnormalities or vital sign abnormalities at screening or baseline
• Received any investigational medicinal products (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose
• Donation of blood within 2 months or donation of plasma within 1 week prior to first dose of study medication
• Are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies in the 14 days before first IMP administration
• Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months before first IMP administration or 3 months for inhaled products
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption as defined in the study protocol
• A confirmed positive alcohol urine test at screening or first 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
• A confirmed positive urine cotinine test at screening or first admission

Where it is running

• Site 01 — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.