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

NCT ID: NCT07240116

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-11
• Study Completion Date: 2025-12-13

Brief Summary

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

Detailed Description

This study will evaluate relative bioavailability of Kinetisol and spray dried dispersion (SDD) miricorilant (CORT118335) tablets. This study will consist of 6 possible treatment sequences across 3 periods for healthy, fed participants. A fourth period may be added to assess the impact of fasted conditions.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Miricorilant Treatment Sequence A, B, C

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment B; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.

Group Type: EXPERIMENTAL

Miricorilant Treatment A

Intervention Type: DRUG

Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration

Miricorilant Treatment B

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration

Miricorilant Treatment C

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration

Miricorilant Treatment Sequence B, C, A

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B, in Period 2, treatment C; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.

Group Type: EXPERIMENTAL

Miricorilant Treatment A

Intervention Type: DRUG

Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration

Miricorilant Treatment B

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration

Miricorilant Treatment C

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration

Miricorilant Treatment Sequence C, A, B

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment A; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.

Group Type: EXPERIMENTAL

Miricorilant Treatment A

Intervention Type: DRUG

Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration

Miricorilant Treatment B

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration

Miricorilant Treatment C

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration

Miricorilant Treatment Sequence B, A, C

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B; in Period 2, treatment A; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.

Group Type: EXPERIMENTAL

Miricorilant Treatment A

Intervention Type: DRUG

Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration

Miricorilant Treatment B

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration

Miricorilant Treatment C

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration

Miricorilant Treatment Sequence A, C, B

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment C; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.

Group Type: EXPERIMENTAL

Miricorilant Treatment A

Intervention Type: DRUG

Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration

Miricorilant Treatment B

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration

Miricorilant Treatment C

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration

Miricorilant Treatment Sequence C, B, A

Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment B; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.

Group Type: EXPERIMENTAL

Miricorilant Treatment A

Intervention Type: DRUG

Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration

Miricorilant Treatment B

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration

Miricorilant Treatment C

Intervention Type: DRUG

Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration

Optional Miricorilant Treatment D

After completion of Period 3, analysis of pharmacokinetic and safety data will be used to decide if Period 4 will be conducted. In Period 4, selected participants will receive a single dose of treatment D in a fasted state on Day 1.

Group Type: EXPERIMENTAL

Miricorilant Treatment D

Intervention Type: DRUG

Miricorilant 100 mg (1 x 100 mg or 2 x 50 mg) Kinetisol IR tablet for oral administration. The tablet strength administered will be decided after Period 3 is complete.

Interventions

Miricorilant Treatment A

Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration

Intervention Type: DRUG

Miricorilant Treatment B

Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration

Intervention Type: DRUG

Miricorilant Treatment C

Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration

Intervention Type: DRUG

Miricorilant Treatment D

Miricorilant 100 mg (1 x 100 mg or 2 x 50 mg) Kinetisol IR tablet for oral administration. The tablet strength administered will be decided after Period 3 is complete.

Intervention Type: DRUG

Other Intervention Names

CORT118335; CORT118335; CORT118335; CORT118335

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Positive drug screen test result at screening or first admission
• Male subjects with pregnant or lactating partners
• Study site or Sponsor employee or immediate family members one
• 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

CORT118335-859

Identifier Type: -

Identifier Source: org_study_id