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

Corcept Therapeutics

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: Miricorilant Treatment D; Drug: Miricorilant Treatment C; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07240116

CORT118335-859

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

18 participants in 7 patient groups

Miricorilant Treatment Sequence A, B, C

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant Treatment A

Drug: Miricorilant Treatment B

Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence B, C, A

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant Treatment A

Drug: Miricorilant Treatment B

Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence C, A, B

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant Treatment A

Drug: Miricorilant Treatment B

Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence B, A, C

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant Treatment A

Drug: Miricorilant Treatment B

Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence A, C, B

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant Treatment A

Drug: Miricorilant Treatment B

Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence C, B, A

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant Treatment A

Drug: Miricorilant Treatment B

Drug: Miricorilant Treatment C

Optional Miricorilant Treatment D

Experimental group

Description:

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.

Treatment:

Drug: Miricorilant Treatment D