Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant

NCT05553470 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT118335-854
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is to determine the effect of hepatic impairment on the pharmacokinetics (PK) of miricorilant following a single oral dose by comparing participants with normal hepatic function with participants with moderate hepatic impairment with or without nonalcoholic steatohepatitis (NASH).

Conditions

Non-alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (3)

• Area under the Concentration-Time Curve (AUC) from Time Zero to the Last Non-Zero Concentration (AUC 0-t)

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose

• AUC from Time Zero to Infinity (AUC0-∞)

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose

• Maximum Observed Plasma Concentration (Cmax)

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose

Secondary Outcomes (5)

• Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

  Up to Day 7

• Number of Participants with One or More Serious Adverse Events (SAEs)

  Up to 30 days after study drug administration

• Number of Participants with Clinically-Significant Vital Sign Abnormality

  Day -1, pre-dose and ~ 1, 2, 4, and 24 hours post-dose.

• Number of Participants with Clinically-Significant 12-Lead Electrocardiogram (ECG) Abnormality

  Day -1, pre-dose and ~1, 2, 4, and 24 hours post-dose, and up to ~Day 7

• Number of Participants with Clinically-Significant Laboratory Test Abnormality

  Day -1 and up to ~Day 7

Study Arms (3)

No Hepatic Impairment

EXPERIMENTAL

Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.

Drug: Miricorilant

Moderate Hepatic Impairment

EXPERIMENTAL

Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.

Drug: Miricorilant

Mild Hepatic Impairment

EXPERIMENTAL

Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.

Drug: Miricorilant

Interventions

Miricorilant DRUG

600 mg miricorilant

Also known as: CORT118335

Mild Hepatic Impairment; Moderate Hepatic Impairment; No Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoker or light smokers (no more than 5 cigarettes/day or nicotine equivalent) with BMI ≥18.0 and ≤32 kg/m2 and body weight ≥50.0 kg.
• Female participants must be non-childbearing or willing to use an acceptable intra-uterine contraceptive device 4 weeks prior and throughout the study and for 90 days after study drug administration.
• Male participants who are sexually active must be willing to use an acceptable contraceptive method from dosing until at least 90 days after study drug administration.
• Total abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant.
• Male participants must be willing to not donate sperm until 90 days following the administration of the study drug.
• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 at screening, by the Modification of Diet in Renal Disease, 4 variable (MDRD4) Equation.
• On a population basis, matched to participants with moderate hepatic impairment according to gender, age (± 10 years), and weight (± 20 %).
• Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic (including cholecystectomy), and metabolic disease.
• Non-clinically significant deviation for laboratory tests results (albumin ≥ the lower limit of normal (LLN), total bilirubin ≤ ULN, aspartate aminotransferase (AST) ≤ upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ ULN, alkaline phosphatase ≤ ULN).
• Participant with stable hepatic impairment (Child-Pugh \[CP\] class A or B according to group)
• Documented parenchymal hepatic disease as evidenced by ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI), or biopsy.
• Participants who have chronic (≥ 6 months) mild or moderate hepatic impairment that has been clinically stable
• Have hepatic impairment as assessed by a CP classification score: Mild (5-6 points), or Moderate (7-9 points) impaired hepatic function with known medical history of liver disease.
• Have non-clinically significant findings at physical examination and in clinically laboratory evaluations.
• Moderate hepatic impairment participants with nonalcoholic steatohepatitis (NASH) only should have a history or presence of metabolic syndrome or type 2 diabetes, clinical characteristics or prior liver biopsy, ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women, and except for participants with prior liver biopsy, participants should have currently or previously one of the following: MRI-iron-corrected T1 (cT1) value \> 800 ms, MRI proton density fat fraction (PDFF) liver fat content ≥ 8 % or FibroScan liver stiffness measurement (LSM) ≥ 8.5 kilopascals (kPa).

You may not qualify if:

• Clinically significant illness or surgery within 4 weeks prior to dosing.
• Gastrointestinal surgery that interferes with physiological absorption and motility or gastric bands.
• Clinically significant history or presence of any gastrointestinal pathology, or unresolved gastrointestinal symptoms that can interfere with drug absorption.
• History of suicidal tendency, disposition to seizures, state of confusion, or clinically relevant psychiatric diseases.
• Any medical condition that could be aggravated by glucocorticoid antagonism, and/or mineralocorticoid antagonism, such as autoimmune disease, rheumatic disease, hypotension, or postural hypotension.
• Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening
• Acute viral hepatitis in the 6 calendar months before the administration of the study drug.
• Positive to Coronavirus disease 2019 (COVID-19) test at screening
• History of Gilbert's syndrome
• Uncontrolled hyperlipidemia
• History of significant drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening, unless for hepatic impaired participants only, the participants uses any of these drugs as prescriptions.
• History of significant alcohol abuse within six months prior to screening or regular use of alcohol within six months prior to the screening visit.
• Donation of plasma within 7 days prior to dosing. Donation or loss of blood of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing.
• Female participants with a positive pregnancy test.
• Participant with a positive alcohol test at screening.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (3)

Site 03

Rialto, California, 92377, United States

Location

Site 01

Miami, Florida, 33136, United States

Location

Site 02

Miami Lakes, Florida, 33104, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

CORT118335

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Joseph Custodio, PhD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: March 3, 2022
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)