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

Primary Purpose

Hepatic Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Relacorilant
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatic Impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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).

Sites / Locations

  • Clinical Pharmacology of Miami, LLC
  • Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

No Hepatic Impairment

Moderate Hepatic Impairment

Mild Hepatic Impairment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cmax of relacorilant plasma metabolites
AUCt of relacorilant plasma metabolites
Number of subjects with one or more treatment-emergent adverse events
Number of subjects with one or more treatment-emergent adverse events by severity

Full Information

First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT06094725
Brief Title
A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant
Official Title
An Open-label, Multiple-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
December 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
If an obvious effect of moderate hepatic impairment on exposure to relacorilant is observed in Part 1, optional Part 2 of the study will be conducted. In Part 2, the effect of mild hepatic impairment on the PK of relacorilant will be evaluated, using control data from the same healthy control subjects who were matched to the subjects in Part 1. Secondary objectives of the study are 1) evaluation of the effect of hepatic impairment on the PK of relacorilant metabolites, and 2) evaluation of safety and tolerability of relacorilant on healthy subjects and those with hepatic impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Hepatic Impairment
Arm Type
Experimental
Arm Description
Subjects with no hepatic impairment will receive relacorilant 300 mg once daily on Days 1 through 10.
Arm Title
Moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
Subjects with moderate hepatic impairment (Child-Pugh Class B) will receive relacorilant 300 mg once daily on Days 1 through 10.
Arm Title
Mild Hepatic Impairment
Arm Type
Experimental
Arm Description
Subjects with mild hepatic impairment (Child-Pugh Class A) will receive relacorilant 300 mg once daily on Days 1 through 10.
Intervention Type
Drug
Intervention Name(s)
Relacorilant
Other Intervention Name(s)
CORT125134
Intervention Description
Relacorilant 300 mg (3 X 100 mg softgel capsules) for oral administration
Primary Outcome Measure Information:
Title
Maximum concentration of plasma relacorilant during the dosing interval (Cmax)
Time Frame
Predose and at serial time points up to 24 hours after dosing on Day 10
Title
Area under the concentration-time curve of plasma relacorilant from time zero to the end of the dosing interval (24 hours) (AUCt)
Time Frame
Predose and at serial time points up to 24 hours after dosing on Day 10
Secondary Outcome Measure Information:
Title
Cmax of relacorilant plasma metabolites
Time Frame
Predose and at serial time points up to 24 hours after dosing on Day 10
Title
AUCt of relacorilant plasma metabolites
Time Frame
Predose and at serial time points up to 24 hours after dosing on Day 10
Title
Number of subjects with one or more treatment-emergent adverse events
Time Frame
Up to Day 20
Title
Number of subjects with one or more treatment-emergent adverse events by severity
Time Frame
Up to Day 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Custodio
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology of Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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