Hepatic ImpairmentPhase 1NCT06094725
A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant
A Phase 1 study testing Relacorilant in people with Hepatic Impairment, run by Corcept Therapeutics at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Relacorilant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jan 2020to 14 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-label, Multiple-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant
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).
Read the 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.
- Conditions
- Hepatic Impairment
- Being tested
- Relacorilant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelacorilantDrug
Also called CORT125134
Relacorilant 300 mg (3 X 100 mg softgel capsules) for oral administration
| Study group | Role | What they receive |
|---|---|---|
| No Hepatic Impairment | Experimental | Subjects with no hepatic impairment will receive relacorilant 300 mg once daily on Days 1 through 10. Receives: 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. Receives: 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. Receives: Drug: Relacorilant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration of plasma relacorilant during the dosing interval (Cmax)
Measured: 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)
Measured: Predose and at serial time points up to 24 hours after dosing on Day 10
Secondary outcomes (4)
Cmax of relacorilant plasma metabolites
Measured: Predose and at serial time points up to 24 hours after dosing on Day 10
AUCt of relacorilant plasma metabolites
Measured: 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
Measured: Up to Day 20
Number of subjects with one or more treatment-emergent adverse events by severity
Measured: Up to Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start6 Jan 2020
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Custodio, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094725
- Sponsor's protocol ID
- CORT125134-128
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant
- ClinicalTrials.gov ID
- NCT06094725
- Acronym / sponsor ID
- CORT125134-128
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Hepatic Impairment | Experimental | Drug: RelacorilantSubjects with no hepatic impairment will receive relacorilant 300 mg once daily on Days 1 through 10. |
| Moderate Hepatic Impairment | Experimental | Drug: RelacorilantSubjects with moderate hepatic impairment (Child-Pugh Class B) will receive relacorilant 300 mg once daily on Days 1 through 10. |
| Mild Hepatic Impairment | Experimental | Drug: RelacorilantSubjects with mild hepatic impairment (Child-Pugh Class A) will receive relacorilant 300 mg once daily on Days 1 through 10. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RelacorilantAlso: CORT125134Relacorilant 300 mg (3 X 100 mg softgel capsules) for oral administration | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, No Hepatic Impairment |
Primary outcome
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
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
4 secondary outcomes
Cmax of relacorilant plasma metabolites
Time frame: Predose and at serial time points up to 24 hours after dosing on Day 10
AUCt of relacorilant plasma metabolites
Time frame: 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
Time frame: Up to Day 20
Number of subjects with one or more treatment-emergent adverse events by severity
Time frame: Up to Day 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Custodio study director
Corcept Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Relacorilant in people with Hepatic Impairment, run by Corcept Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.