Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant

NCT06928779 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT113176-657
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

This study will compare the pharmacokinetics (PK) of dazucorilant (CORT113176) between participants with normal hepatic function and participants with hepatic impairment.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (5)

• Area under the concentration-time curve from time zero to the last non-zero concentration (AUC0-t) of dazucorilant

  Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing

• Area under the concentration-time curve from time zero to infinity (extrapolated) (AUC0-inf) of dazucorilant

  Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing

• Maximum observed concentration (Cmax) of dazucorilant

  Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing

• Time to maximum concentration (Tmax) of dazucorilant

  Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing

• Apparent clearance (Cl/F) of dazucorilant

  Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing

Secondary Outcomes (5)

• Number of participants with 1 or more adverse events

  Up to Day 7

• Number of participants with 1 or more clinically significant abnormal vital signs

  Up to Day 7

• Number of participants with 1 or more clinically significant abnormal electrocardiogram (ECG) result

  Up to Day 7

• Number of participants with 1 or more clinically significant abnormal clinical laboratory result

  Up to Day 7

• Number of participants with 1 or more clinically significant abnormal physical examination result

  Up to Day 7

Study Arms (3)

Moderate Hepatic Impairment

EXPERIMENTAL

On Day 1, each participant with moderate hepatic impairment will receive a single oral dose of dazucorilant 300 mg.

Drug: Dazucorilant

Matched Healthy Participants

EXPERIMENTAL

Healthy participants will be matched to those with moderate hepatic impairment as to gender, age (± 10 years of the mean), and weight (± 20% of the mean). On Day 1, each healthy participant will receive a single oral dose of dazucorilant 300 mg.

Drug: Dazucorilant

Mild Hepatic Impairment

EXPERIMENTAL

On Day 1, each participant with mild hepatic impairment will receive a single oral dose of dazucorilant 300 mg. This arm may be enrolled after review of interim PK evaluation of the effects of moderate hepatic impairment.

Drug: Dazucorilant

Interventions

Dazucorilant DRUG

Dazucorilant 300 mg (4 X 75 mg) soft gelatin capsules for oral administration

Also known as: CORT113176

Matched Healthy Participants; Mild Hepatic Impairment; Moderate Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A non-smoker (no use of tobacco or nicotine products within 3 months prior to Screening) or light smokers (no more than 5 cigarettes/day or nicotine equivalent)
• Has body mass index (BMI) ≥18.0 and ≤32 kg/m\^2 and body weight ≥50.0 kg
• Female participants (except for post-menopausal and surgically sterile women) who are sexually active with a non-sterile male partner must be willing to use 1 of the acceptable contraceptive methods described in the protocol throughout the study and for 90 days after study drug administration
• Female participants of non-childbearing potential must be post-menopausal or surgically sterile
• Male participants who are not vasectomized at least 6 months prior to study drug administration and who are sexually active with a non-sterile female partner must be willing to use 1 of the acceptable contraceptive methods described in the protocol from dosing until at least 90 days after study drug administration
• Male participants must be willing not to donate sperm until 90 days following the administration of the study drug
• Has estimated glomerular filtration rate ≥60 mL/min/1.73 m\^2 at Screening
• Is able to understand the study procedures, agree to abide by the study restrictions, and provide signed informed consent to participate in the study.
• Healthy as defined by: a) on a population basis, matched to participants with moderate hepatic impairment according to gender, age (±10 years), and weight (±20%); b) BMI ≥18.0 and ≤32 kg/m\^2; c) the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic (including cholecystectomy), and metabolic disease; and d) no clinically significant deviation for laboratory tests results.
• Documented parenchymal hepatic disease evidenced by, e.g., ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI), Fibroscan, or biopsy
• Chronic (≥6 months) hepatic impairment (of any etiology) that has been clinically stable for at least 1 month prior to Screening as determined by the Principal Investigator (PI). Participants must also remain stable throughout the screening period
• Has hepatic impairment as assessed by a Child-Pugh classification score: Mild (5-6 points) or Moderate (7-9 points) according to hepatic function group
• Has normal or non-clinically significant findings at physical examination and normal limits or non-clinically significant deviations in clinical laboratory evaluations with the exception of findings that in the opinion of the PI are consistent with participant's hepatic impairment or other stable chronic medical condition
• Has a stable drug regimen for 14 days prior to study drug administration. Medications are allowed if they are essential for the management of hepatic impairment and the treatment of concomitant stable medical conditions for the hepatically impaired participants.

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 (e.g. gastric bypass, duodenectomy) or gastric bands
• Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting) that can interfere with drug absorption
• History of suicidal tendency, disposition to seizures, state of confusion, or clinically relevant psychiatric diseases
• Has any medical condition that could be aggravated by glucocorticoid antagonism, such as autoimmune disease or rheumatic disease
• Has clinically significant ECG or vital sign abnormalities at Screening
• Has acute viral hepatitis in the 6 calendar months before the administration of the study drug
• Has Gilbert's syndrome, an inherited (genetic) liver disorder that affects the body's ability to process bilirubin
• Has uncontrolled hyperlipidemia (abnormally high levels of lipids in the blood), which include cholesterol and triglycerides) as judged by the PI
• History of significant drug abuse within 1 year prior to Screening or recreational use of soft drugs (such as marijuana) within 1 month, or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to Screening, unless for hepatic impaired participants only, the participant uses any of these drugs as prescriptions
• History of significant alcohol abuse within 6 months prior to Screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week \[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\])
• Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening or menses) 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 at Screening or Day -1
• Has a positive alcohol (breath or urine) test at Screening or Day -1
• Has a history of clinically significant hypersensitivity to dazucorilant, other related drugs, or any of the ingredients or excipients of the study drug

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (2)

Site 2

Rialto, California, 92377, United States

Location

Site 1

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

CORT113176

Study Officials

• Jeevan Kunta, 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: April 8, 2025
• First Posted: April 15, 2025
• Study Start: October 8, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)