Hepatic ImpairmentPhase 1NCT06928779
Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant
A Phase 1 study testing Dazucorilant in people with Hepatic Impairment, run by Corcept Therapeutics at 2 sites in United States.
Trial summary
This study will compare the pharmacokinetics (PK) of dazucorilant (CORT113176) between participants with normal hepatic function and participants with hepatic impairment. 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?
- Dazucorilant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2024to 9 Dec 2024
- 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
- 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
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- 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.
- Additional Inclusion Criteria for Healthy Control Group Participants Only:
- 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.
- Additional Inclusion Criteria for Participants with Hepatic Impairment Only:
- 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.
Who cannot join
- 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
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- 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
- Previous participation in a study with dazucorilant administration
- Participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device
- Participants who have taken a) oral, parenteral, depot or intra-articular glucocorticoids within 12 calendar months prior to study drug administration or b) intranasal, topical, or inhaled glucocorticoids within 2 weeks (or 5 half-lives, if longer) prior to study drug administration
- Use of any drugs, herbal products, or other substances known to induce or inhibit hepatic drug metabolism (including St. John's wort) within 30 days prior to study drug administration
- Male participants (including men who have had a vasectomy) with a pregnant or lactating partner
- Breast-feeding female participants
- Has inability or difficulty to swallow soft gelatin capsules
- Has inability to be venipunctured and/or tolerate catheter venous access
- Is an employee or family member of a contract research organization or Sponsor
- Any reason which, in the opinion of the PI, would prevent the participant from participating in the study.
- Additional Exclusion Criteria for Healthy Control Group Participants Only:
- Has previously documented parenchymal hepatic disease evidenced by, for example, ultrasonography, CT, MRI, or biopsy. There is no requirement that control group participants have previously undergone any of these investigations, but results of any that have been performed must be negative
- Has any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results, or positive test for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at Screening
- Participants using medication other than topical products without significant systemic absorption: a) prescription medication within 14 days prior to the administration of study drug, b) over-the-counter (OTC) products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily), and c) a depot injection or an implant of any drug within 3 months prior to the administration of study drug
- Participants with a positive urine drug screen at Screening or check-in.
- Additional Exclusion Criteria for Participants with Hepatic Impairment Only:
- Has clinically significant unstable medical conditions or clinically significant acute exacerbation of hepatic disease within 30 days of study drug administration in the opinion of the PI
- Has clinically significant abnormalities of laboratory, ECG, or clinical data that would preclude participation in the study in the opinion of the PI
- Has presence of chronic kidney disease
- Has presence of hepatocellular carcinoma or acute hepatic disease from infection or drug toxicity
- Has presence of clinically significant history of lactic acidosis and severe hepatomegaly with steatosis
- Has presence of active stage 2, 3, or stage 4 hepatic encephalopathy
- Has evidence of severe ascites at PI's discretion
- Has Type 1 or uncontrolled Type 2 diabetes (decompensated diabetes, glycated hemoglobin HbA1c >10 %)
- Has presence of surgically-created or transjugular intrahepatic portal systemic shunts
- Has a positive test for HIV
- Has a positive drug screen at Screening or check-in. Participants who have a positive drug screen due to prescription drug use will be allowed if approved by the PI
- Use of prohibited concomitant medication. At the discretion of the PI and Medical Monitor and with agreement of the participant's usual physician if applicable, a suitable substitute medication may be prescribed to replace the prohibited medication
- Has history or clinical evidence of hepatic decompensation
- Has history of liver transplant, or current placement on a liver transplant list
- Use of medications for the timeframes specified below, with the exception of medications exempted by the PI on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety: a) prescription medications from 14 days prior to dosing (exceptions apply), or b) OTC and natural health products from 7 days prior to dosing unless a hepatic participant is taking such products for their routine care, with the exception of the occasional use of acetaminophen.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 1
Miami, Florida, 33014
Site 2
Rialto, California, 92377
About this study
Official title: An Open-Label, Single-Dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant
This study will compare the pharmacokinetics (PK) of dazucorilant (CORT113176) between participants with normal hepatic function and participants with hepatic impairment.
Read the detailed description
Initially, participants with moderate hepatic impairment and healthy control participants matched as to gender, age, and weight will be enrolled. After completing screening assessments, participants will receive a single dose of dazucorilant followed by an observation period of 7 days. Based on the observed effect of moderate hepatic impairment on the dazucorilant PK profile, and review of safety data, a group of participants with mild hepatic impairment, matched to the enrolled healthy control participants, may be enrolled to evaluate the effects of mild hepatic impairment on dazucorilant PK.
- Conditions
- Hepatic Impairment
- Being tested
- Dazucorilant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DazucorilantDrug
Also called CORT113176
Dazucorilant 300 mg (4 X 75 mg) soft gelatin capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | On Day 1, each participant with moderate hepatic impairment will receive a single oral dose of dazucorilant 300 mg. Receives: 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. Receives: 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. Receives: Drug: Dazucorilant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to the last non-zero concentration (AUC0-t) of dazucorilant
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 7
Number of participants with 1 or more clinically significant abnormal vital signs
Measured: Up to Day 7
Number of participants with 1 or more clinically significant abnormal electrocardiogram (ECG) result
Measured: Up to Day 7
Number of participants with 1 or more clinically significant abnormal clinical laboratory result
Measured: Up to Day 7
Number of participants with 1 or more clinically significant abnormal physical examination result
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start8 Oct 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeevan Kunta, PhD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928779
- Sponsor's protocol ID
- CORT113176-657
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 15 Apr 2025
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant
- ClinicalTrials.gov ID
- NCT06928779
- Acronym / sponsor ID
- CORT113176-657
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 15 Apr 2025 (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.
This study will compare the pharmacokinetics (PK) of dazucorilant (CORT113176) between participants with normal hepatic function and participants with hepatic impairment.
Detailed description
Initially, participants with moderate hepatic impairment and healthy control participants matched as to gender, age, and weight will be enrolled. After completing screening assessments, participants will receive a single dose of dazucorilant followed by an observation period of 7 days. Based on the observed effect of moderate hepatic impairment on the dazucorilant PK profile, and review of safety data, a group of participants with mild hepatic impairment, matched to the enrolled healthy control participants, may be enrolled to evaluate the effects of mild hepatic impairment on dazucorilant PK.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Drug: DazucorilantOn Day 1, each participant with moderate hepatic impairment will receive a single oral dose of dazucorilant 300 mg. |
| Matched Healthy Participants | Experimental | Drug: DazucorilantHealthy 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. |
| Mild Hepatic Impairment | Experimental | Drug: DazucorilantOn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (46 listed)
- 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
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 |
|---|---|---|
| DazucorilantAlso: CORT113176Dazucorilant 300 mg (4 X 75 mg) soft gelatin capsules for oral administration | Drug | Matched Healthy Participants, Mild Hepatic Impairment, Moderate Hepatic Impairment |
Primary outcome
Area under the concentration-time curve from time zero to the last non-zero concentration (AUC0-t) of dazucorilant
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing
5 secondary outcomes
Number of participants with 1 or more adverse events
Time frame: Up to Day 7
Number of participants with 1 or more clinically significant abnormal vital signs
Time frame: Up to Day 7
Number of participants with 1 or more clinically significant abnormal electrocardiogram (ECG) result
Time frame: Up to Day 7
Number of participants with 1 or more clinically significant abnormal clinical laboratory result
Time frame: Up to Day 7
Number of participants with 1 or more clinically significant abnormal physical examination result
Time frame: Up to Day 7
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 15 Apr 2025.
- 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.
Jeevan Kunta, PhD 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 Dazucorilant 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 16 inclusion and 46 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 15 Apr 2025. 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?
Area under the concentration-time curve from time zero to the last non-zero concentration (AUC0-t) of dazucorilant (time frame: Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing). The study lists 5 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 15 Apr 2025.