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

An Open-Label, Randomized, 3-Treatment, 3-Period, 6-Sequence, Balanced Crossover Study to Characterize the Relative Bioavailability of Miricorilant Administered as 50-mg and 100-mg Kinetisol Tablets vs the 50-mg Spray Dried Dispersion Tablet Formulation With an Optional Food Effect Assessment in Healthy Adult Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Miricorilant Treatment A; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C; Drug: Miricorilant Treatment D

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Miricorilant Treatment A; Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment B; Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment C; Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration; Other Names: CORT118335
Experimental: 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.	Drug: Miricorilant Treatment A; Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment B; Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment C; Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration; Other Names: CORT118335
Experimental: 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.	Drug: Miricorilant Treatment A; Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment B; Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment C; Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration; Other Names: CORT118335
Experimental: 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.	Drug: Miricorilant Treatment A; Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment B; Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment C; Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration; Other Names: CORT118335
Experimental: 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.	Drug: Miricorilant Treatment A; Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment B; Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment C; Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration; Other Names: CORT118335
Experimental: 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.	Drug: Miricorilant Treatment A; Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment B; Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration; Other Names: CORT118335; Drug: Miricorilant Treatment C; Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration; Other Names: CORT118335
Experimental: 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.	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.; Other Names: CORT118335

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of Maximum Observed Concentration (Tmax) of Miricorilant	Predose and at serial timepoints up to 72 hours postdose
Maximum Observed Concentration (Cmax) of Miricorilant	Predose and at serial timepoints up to 72 hours postdose
Concentration at 24 Hours Postdose (C24) of Miricorilant	Predose and at serial timepoints up to 24 hours postdose
Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC[0-last]) of Miricorilant	Predose and at serial timepoints up to 72 hours postdose
Area Under the Curve from Time 0 Extrapolated to Infinity (AUC[0-inf]) of Miricorilant	Predose and at serial timepoints up to 72 hours postdose
Terminal Elimination Half-Life (T1/2) of Miricorilant	Predose and at serial timepoints up to 72 hours postdose
Relative Bioavailability (Frel) for Miricorilant Based on Cmax	Predose and at serial timepoints up to 72 hours postdose
Frel for Miricorilant based on AUC(0-last)	Predose and at serial timepoints up to 72 hours postdose
Frel for Miricorilant Based on AUC(0-inf)	Predose and at serial timepoints up to 72 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Abnormal, Clinically Significant Clinical Laboratory Findings	Clinical laboratory findings include hematology, clinical chemistry, urinalysis.	Day -1 and 72 hours postdose in periods 3 and 4
Number of Participants with Abnormal, Clinically Significant 12-Lead Electrocardiogram (ECG) Findings		Day -1, predose, and at 4 and 72 hours postdose in every study period
Number of Participants with Abnormal, Clinically Significant Vital Sign Findings		Day -1, predose, and at serial time points up to 72 hours postdose in every study period
Number of Participants with Abnormal, Clinically Significant Physical Exam Findings		72 hours postdose in periods 3 and 4
Number of Participants with 1 or More Adverse Events		Screening up to 30 days postdose

Collaborators and Investigators

• Sponsor: Corcept Therapeutics
• Investigators: Study Director: Joseph Custodio, PhD, Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Actual): March 3, 2026
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: November 7, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: CORT118335
• Other Study ID Numbers: CORT118335-859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No