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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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).

Key facts

Study ID: NCT06094725
Run by: Corcept Therapeutics
People needed: 30
Starts: 2020-01-06
Expected to finish: 2020-12-14
Last updated by the study team: 2023-10-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.
Subjects with normal hepatic function must also satisfy the following inclusion criteria:
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.
Subjects with moderate or mild hepatic impairment must also satisfy the following inclusion criteria:
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
If a subject has nonhepatic abnormal clinical laboratory results, these results are considered not clinically relevant by the Principal Investigator (or designee) and the medical monitor.

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.
Additional exclusion criteria for subjects with moderate or mild hepatic impairment:
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).

Where it is running

Clinical Pharmacology of Miami, LLC — Miami, Florida, United States
Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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