Hepatic ImpairmentPhase 1NCT02121860
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
A Phase 1 study testing IDN-6556 in people with Hepatic Impairment and Liver Diseases, run by Conatus Pharmaceuticals Inc. at 3 sites in United States.
Trial summary
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Liver Diseases, Digestive System Diseases
- What is being tested?
- IDN-6556
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Jul 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects:
- Male or female subjects 18 years of age or older, able to provide written informed consent, understand and comply with all scheduled visits, and other requirements of the study
- Body mass index (BMI) 18.0 - 40.0 kg/m2 and body weight >45 kg
- Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug
- Matched Healthy Volunteers:
- Medically healthy as determined by the Investigator
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- Supine blood pressure ≤145/90 mmHg
- No significant uncontrolled systemic or major illness that, in the opinion of the Investigator, would preclude the subject from participating in and completing the study
- Demographically comparable to subjects with hepatic impairment as follows:
- Mean body weight within ±15 kg
- Mean age within ±10 years
- Similar gender ratio
- Subjects with Hepatic Impairment:
- Evidence of hepatic disease
- Score ≥ 2 on one of the Child-Pugh parameters, or
- Histological or imaging diagnosis of cirrhosis, or
- Presence of esophageal varices, or
- Abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels
- Meet one of the following criteria for Child-Pugh classification for hepatic impairment during Screening
- Mild hepatic impairment: Class A (Child-Pugh Scores 5-6 points)
- Moderate hepatic impairment: Class B (Child-Pugh Scores 7-9 points)
- Severe hepatic impairment: Class C (Child Pugh Scores 10-15 points)
- Supine blood pressure ≤160/100 mmHg
Who cannot join
- All Subjects:
- Known infection with human immunodeficiency virus (HIV) upon serological testing
- Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.)
- History of febrile illness within 5 days prior to dosing Note: Subjects can be rescreened once afebrile and more than 5 days have elapsed since the febrile illness.
- Known ongoing drug abuse within one month prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during Screening and/or at Day -1
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- Subjects with active or history of malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
- Dosing in another clinical trial within 30 days prior to the study drug administration
- If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
- Matched Healthy Volunteers:
- Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver disease, elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is considered clinically significant by the Investigator, etc.)
- Screening creatinine clearance <80 mL/min using the Cockcroft-Gault equation
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of >450 milliseconds (msec)
- History of regular alcohol consumption exceeding 28 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of spirits) within 6 months of Screening
- Subjects with Hepatic Impairment:
- Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment during Screening period and up to Day -1 (e.g., advanced ascites, infection of ascites, fever, active gastrointestinal bleeding)
- History of liver transplant, or have a transjugular intrahepatic portosystemic shunt, and/or have undergone portacaval shunting
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec)
- Screening creatinine clearance <50 mL/min using the Cockcroft-Gault equation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Avail Clinical Research
DeLand, Florida, 32720
University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of IDN-6556 in Subjects With Hepatic Impairment and in Matched Healthy Volunteers
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function.
- Being tested
- IDN-6556
- Keywords
- Hepatic Impairment, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Liver Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDN-6556Drug
Also called emricasan, PF-03491390
| Study group | Role | What they receive |
|---|---|---|
| Chil-Pugh Class A | Experimental | All subjects with mild hepatic impairment received a single 50 mg oral dose of IDN-6556 Receives: Drug: IDN-6556 |
| Chil-Pugh Class B | Experimental | All subjects with moderate hepatic impairment received a single 50 mg oral dose of IDN-6556 Receives: Drug: IDN-6556 |
| Chil-Pugh Class C | Experimental | All subjects with severe hepatic impairment received a single 50 mg oral dose of IDN-6556 Receives: Drug: IDN-6556 |
| Normal Hepatic Function | Experimental | All healthy volunteers subjects received a single 50 mg oral dose of IDN-6556 Receives: Drug: IDN-6556 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the plasma concentration curve (AUC) to 12 hours post-dose (AUC0-12); AUC to the last observed plasma concentration (AUClast);
Measured: 48 Hours
Cmax
Maximum concentration (Cmax)
Measured: 48 Hours
Secondary outcomes (2)
Levels of cCK18/M30
Caspase-cleaved cytokeratin levels (cCK18M30)
Measured: predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose
Levels of Caspase 3/7 RLU
Concentration of Caspase 3/7 Relative Light Units
Measured: predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Hagerty, MD, Study chair, Conatus Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121860
- Sponsor's protocol ID
- IDN-6556-08
- Status last verified
- Jan 2016
- First submitted
- 18 Apr 2014
- Last updated
- 24 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of IDN-6556 in Subjects With Hepatic Impairment and in Matched Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02121860
- Acronym / sponsor ID
- IDN-6556-08
- Keywords
- Hepatic Impairment, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Conatus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Posted 24 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chil-Pugh Class A | Experimental | Drug: IDN-6556All subjects with mild hepatic impairment received a single 50 mg oral dose of IDN-6556 |
| Chil-Pugh Class B | Experimental | Drug: IDN-6556All subjects with moderate hepatic impairment received a single 50 mg oral dose of IDN-6556 |
| Chil-Pugh Class C | Experimental | Drug: IDN-6556All subjects with severe hepatic impairment received a single 50 mg oral dose of IDN-6556 |
| Normal Hepatic Function | Experimental | Drug: IDN-6556All healthy volunteers subjects received a single 50 mg oral dose of IDN-6556 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female subjects 18 years of age or older, able to provide written informed consent, understand and comply with all scheduled visits, and other requirements of the study
- Body mass index (BMI) 18.0 - 40.0 kg/m2 and body weight >45 kg
- Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug
- Medically healthy as determined by the Investigator
- Supine blood pressure ≤145/90 mmHg
Key exclusion criteria (19 listed)
- Known infection with human immunodeficiency virus (HIV) upon serological testing
- Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.)
- History of febrile illness within 5 days prior to dosing Note: Subjects can be rescreened once afebrile and more than 5 days have elapsed since the febrile illness.
- Known ongoing drug abuse within one month prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during Screening and/or at Day -1
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 |
|---|---|---|
| IDN-6556Also: emricasan, PF-03491390 | Drug | Chil-Pugh Class A, Chil-Pugh Class B, Chil-Pugh Class C, Normal Hepatic Function |
Primary outcome
AUC
Time frame: 48 Hours
Area under the plasma concentration curve (AUC) to 12 hours post-dose (AUC0-12); AUC to the last observed plasma concentration (AUClast);
Cmax
Time frame: 48 Hours
Maximum concentration (Cmax)
2 secondary outcomes
Levels of cCK18/M30
Time frame: predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose
Levels of Caspase 3/7 RLU
Time frame: predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dave Hagerty, MD study chair
Conatus Pharmaceuticals Inc.
3 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 IDN-6556 in people with Hepatic Impairment and Liver Diseases, run by Conatus Pharmaceuticals Inc. at 3 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 23 inclusion and 19 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC (time frame: 48 Hours). 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 24 Feb 2016.