A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant

NCT06094725 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT125134-128
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this multiple-dose, adaptive design study is to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of relacorilant relative to healthy matched control male and female subjects (Part 1).

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Maximum concentration of plasma relacorilant during the dosing interval (Cmax)

  Predose and at serial time points up to 24 hours after dosing on Day 10

• Area under the concentration-time curve of plasma relacorilant from time zero to the end of the dosing interval (24 hours) (AUCt)

  Predose and at serial time points up to 24 hours after dosing on Day 10

Secondary Outcomes (4)

• Cmax of relacorilant plasma metabolites

  Predose and at serial time points up to 24 hours after dosing on Day 10

• AUCt of relacorilant plasma metabolites

  Predose and at serial time points up to 24 hours after dosing on Day 10

• Number of subjects with one or more treatment-emergent adverse events

  Up to Day 20

• Number of subjects with one or more treatment-emergent adverse events by severity

  Up to Day 20

Study Arms (3)

No Hepatic Impairment

EXPERIMENTAL

Subjects with no hepatic impairment will receive relacorilant 300 mg once daily on Days 1 through 10.

Drug: Relacorilant

Moderate Hepatic Impairment

EXPERIMENTAL

Subjects with moderate hepatic impairment (Child-Pugh Class B) will receive relacorilant 300 mg once daily on Days 1 through 10.

Drug: Relacorilant

Mild Hepatic Impairment

EXPERIMENTAL

Subjects with mild hepatic impairment (Child-Pugh Class A) will receive relacorilant 300 mg once daily on Days 1 through 10.

Drug: Relacorilant

Interventions

Relacorilant DRUG

Relacorilant 300 mg (3 X 100 mg softgel capsules) for oral administration

Also known as: CORT125134

Mild Hepatic Impairment; Moderate Hepatic Impairment; No 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:

• Able to understand the purpose and risks of the study and is willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures
• Provide written informed consent before any study-specific procedure is performed
• Male or a nonpregnant, nonlactating female judged to be in good health, except for allowance of health conditions consistent with hepatic impairment
• Body mass index (BMI) between 18 and 32 kg/m\^2, inclusive, and a body weight more than 50 kg (110 pounds)
• Estimated glomerular filtration rate (eGFR) ≥80 mL/minute/1.73 m\^2
• Suitable veins for multiple venipuncture/cannulation
• Agrees to limit smoking or use of tobacco or nicotine-containing products to less than 5 cigarettes or uses per day
• Willing to comply with study restrictions as described in the protocol
• Female subject is of either nonchildbearing potential (ie, postmenopausal or permanently sterilized) or uses highly effective contraception with low user-dependency, as described in the protocol.
• Clinical laboratory results within the reference range at Screening and Day -1, unless considered not clinically significant by the Principal Investigator
• Negative screening results for hepatitis B surface antigen, hepatitis C virus antibody, and HIV antibodies.
• Documented parenchymal hepatic disease
• Liver dysfunction of moderate (Child-Pugh Class B \[score of 7 to 9\]; Part 1) or mild (Child-Pugh Class A \[score of 5 to 6\]; Part 2) severity
• Stable hepatic impairment defined as no clinically significant change in disease status within the last 30 days
• On a stable dose of medication and/or treatment regimen at least 2 weeks before study drug dosing

You may not qualify if:

• An employee or immediate family member of the Clinical Research Unit (CRU) or the Sponsor
• Has been previously enrolled in any study of relacorilant
• Has multiple clinically significant drug allergies or is allergic to any of the components of relacorilant
• Has a condition that could be aggravated by excessive glucocorticoid receptor antagonism. Subjects with inactive seasonal hay fever or childhood asthma may be included.
• Has a history of malabsorption syndrome or previous gastrointestinal surgery that could affect drug absorption or metabolism
• Has Gilberts syndrome
• Has current or previous (within a 1-year period) alcohol or substance abuse and/or dependence
• Has evidence of acute viral hepatitis in the 3 calendar months before the first dose of study drug
• In the 2 calendar months before the first dose of study drug, subject has: donated/lost blood or plasma in excess of 400 mL, or received an investigational drug
• Has a positive result for alcohol or drugs of abuse at Screening or upon admission to the CRU
• Has clinically relevant abnormal vital signs, physical examination, laboratory tests, or 12-lead ECG findings at Screening and/or before the first dose of study drug, other than those associated with chronic hepatic impairment
• Has taken any prohibited prior medication, as described in the protocol
• Has any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Principal Investigator.
• Has hepatic encephalopathy of Grade 2 that has not been controlled with medication for the previous 3 calendar months before Screening or of Grade 3 or higher within the previous 3 calendar months before Screening, regardless of use of medication for the treatment of hepatic encephalopathy
• Has a history of liver transplantation, hepatocellular carcinoma, portosystemic shunt, or acute liver disease (eg, caused by infection or drug toxicity).

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (2)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

relacorilant

Study Officials

• Joseph Custodio

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: January 6, 2020
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)