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

NCT07240116 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT118335-859
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Number of Participants with Abnormal, Clinically Significant Clinical Laboratory Findings

  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

Study Arms (7)

Miricorilant Treatment Sequence A, B, C

EXPERIMENTAL

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; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence B, C, A

EXPERIMENTAL

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; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence C, A, B

EXPERIMENTAL

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; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence B, A, C

EXPERIMENTAL

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; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence A, C, B

EXPERIMENTAL

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; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C

Miricorilant Treatment Sequence C, B, A

EXPERIMENTAL

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; Drug: Miricorilant Treatment B; Drug: Miricorilant Treatment C

Optional Miricorilant Treatment D

EXPERIMENTAL

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

Interventions

Miricorilant Treatment B DRUG

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

Also known as: CORT118335

Miricorilant Treatment Sequence A, B, C; Miricorilant Treatment Sequence A, C, B; Miricorilant Treatment Sequence B, A, C; Miricorilant Treatment Sequence B, C, A; Miricorilant Treatment Sequence C, A, B; Miricorilant Treatment Sequence C, B, A

Miricorilant Treatment C DRUG

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

Also known as: CORT118335

Miricorilant Treatment Sequence A, B, C; Miricorilant Treatment Sequence A, C, B; Miricorilant Treatment Sequence B, A, C; Miricorilant Treatment Sequence B, C, A; Miricorilant Treatment Sequence C, A, B; Miricorilant Treatment Sequence C, B, A

Miricorilant Treatment D 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.

Also known as: CORT118335

Optional Miricorilant Treatment D

Miricorilant Treatment A DRUG

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

Also known as: CORT118335

Miricorilant Treatment Sequence A, B, C; Miricorilant Treatment Sequence A, C, B; Miricorilant Treatment Sequence B, A, C; Miricorilant Treatment Sequence B, C, A; Miricorilant Treatment Sequence C, A, B; Miricorilant Treatment Sequence C, B, A

Eligibility Criteria

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

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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Site 01

Miami, Florida, 33126, United States

Location

MeSH Terms

Interventions

CORT118335

Study Officials

• Joseph Custodio, PhD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 20, 2025
• Study Start: September 11, 2025
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)