Renal ImpairmentPhase 1NCT02039817
PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
A Phase 1 study testing IDN-6556 in people with Renal Impairment and Renal Insufficiency, run by Conatus Pharmaceuticals Inc. at 2 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 severe renal impairment and matched healthy volunteers with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Renal Insufficiency, Kidney Disease
- 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
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Apr 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 - 75 years of age, 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 >50 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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- Screening creatinine clearance ≥90 mL/min using the Cockcroft-Gault equation
- 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 severe renal impairment as follows:
- Mean body weight within ±10 kg
- Mean age within ±5 years
- Similar gender ratio
- Severe Renal Impaired Subjects:
- Screening creatinine clearance (CLCR) <30 mL/min using the Cockcroft-Gault equation
- Supine blood pressure ≤170/110 mmHg
- Documented renal impairment indicated by reduced creatinine clearance within 12 months of screening or longer
- Stable renal function as evidenced by ≤30% difference in two measurements of creatinine clearance on two separate occasions separated by at least 28 days with one measurement being the value at screening.
Who cannot join
- History of renal trasplant
- Acute renal failure
- Subjects undergoing any method of dialysis or hemofiltration
- Evidence or history of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, 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
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- 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.)
- Known infection with human immunodeficiency virus (HIV) upon serological testing
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec) for subjects with severe renal impairment or >450 msec for matched healthy volunteers
- Subjects with active or history of malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Avail Clinical Research
DeLand, Florida, 32720
University of Miami
Miami, Florida, 33136
About this study
Official title: An Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of IDN-6556 in Subjects With Severe Renal 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 severe renal impairment and matched healthy volunteers with normal renal function.
- Conditions
- Renal Impairment, Renal Insufficiency, Kidney Disease, Kidney Diseases
- Being tested
- IDN-6556
- Keywords
- pharmacokinetics, pharmacodynamics, renal impairment
- Medical subject headings
- Renal Insufficiency, Kidney 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 |
|---|---|---|
| Healthy Volunteers | Experimental | All subjects receive a single 50 mg oral dose of IDN-6556 Receives: Drug: IDN-6556 |
| Severe Renal Impairment | Experimental | All subjects receive 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) parameters include AUC0-12, AUCinf, AUClast
Measured: 48 hours
Cmax
Maximum concentration (Cmax)
Measured: 48 hours
Secondary outcomes (1)
Levels of cCK18
Biomarker cCK18 (Cleaved cytokeratin 18) PK evaluations from pre-dose to 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 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 Renal 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
- 16 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
- NCT02039817
- Sponsor's protocol ID
- IDN-6556-05
- Status last verified
- Dec 2015
- First submitted
- 15 Jan 2014
- Last updated
- 28 Jan 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 28 Jan 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 Severe Renal Impairment and in Matched Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02039817
- Acronym / sponsor ID
- IDN-6556-05
- Conditions
- Renal Impairment, Renal Insufficiency, Kidney Disease, Kidney Diseases
- Keywords
- pharmacokinetics, pharmacodynamics, renal impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Conatus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 28 Jan 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 severe renal impairment and matched healthy volunteers with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: IDN-6556All subjects receive a single 50 mg oral dose of IDN-6556 |
| Severe Renal Impairment | Experimental | Drug: IDN-6556All subjects receive 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 (18 listed)
- Male or female subjects 18 - 75 years of age, 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 >50 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
- Screening creatinine clearance ≥90 mL/min using the Cockcroft-Gault equation
Key exclusion criteria (10 listed)
- History of renal trasplant
- Acute renal failure
- Subjects undergoing any method of dialysis or hemofiltration
- Evidence or history of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, 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.)
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 | Healthy Volunteers, Severe Renal Impairment |
Primary outcome
AUC
Time frame: 48 hours
Area under the plasma concentration curve (AUC) parameters include AUC0-12, AUCinf, AUClast
Cmax
Time frame: 48 hours
Maximum concentration (Cmax)
1 secondary outcome
Levels of cCK18
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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.
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 IDN-6556 in people with Renal Impairment and Renal Insufficiency, run by Conatus Pharmaceuticals Inc. 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 10 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 28 Jan 2016. 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?
Yes. Results are posted in the registry (first posted 28 Jan 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 28 Jan 2016.