Back to resultsA Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects
Primary Purpose
Liver Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
naproxcinod
Sponsored by
About this trial
This is an interventional basic science trial for Liver Disease focused on measuring hepatic impairment
Eligibility Criteria
Inclusion Criteria:
- Male or Female, age 40 to 75 years with stable hepatic insufficiency conforming to Child-Pugh classification B OR
- Male or Female, age 40 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health
Exclusion Criteria:
- Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except lose dose aspirin
- History of renal impairment
- Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
- Clinically relevant abnormal ECG
- Alcohol or drug abuse within the last 6 months
- Any significant or chronic disease (except hepatic insufficiency for the patient cohort) which may interfere with study evaluations
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
750 mg naproxcinod
Outcomes
Primary Outcome Measures
To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects
Secondary Outcome Measures
To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00621881
Brief Title
A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects
Official Title
A Phase 1, Repeated-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750 mg Bid Administered to Patients With Impaired Hepatic Function Compared to Matching Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
NicOx
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.
Detailed Description
This is an open-label, non-randomized, parallel-group study that will be conducted at two study sites. Patients with hepatic impairment and matched healthy subjects will receive naproxcinod 750 mg bid for 6 days and qd for the last day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
hepatic impairment
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
750 mg naproxcinod
Intervention Type
Drug
Intervention Name(s)
naproxcinod
Intervention Description
750 mg bid
Primary Outcome Measure Information:
Title
To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects
Time Frame
8 days
Secondary Outcome Measure Information:
Title
To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects.
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or Female, age 40 to 75 years with stable hepatic insufficiency conforming to Child-Pugh classification B OR
Male or Female, age 40 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health
Exclusion Criteria:
Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except lose dose aspirin
History of renal impairment
Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
Clinically relevant abnormal ECG
Alcohol or drug abuse within the last 6 months
Any significant or chronic disease (except hepatic insufficiency for the patient cohort) which may interfere with study evaluations
Facility Information:
City
Miami
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects
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