Back to resultsA Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function (HCT3012-X-106)
Primary Purpose
Renal Failure
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
naproxcinod
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.
- Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health
Exclusion Criteria:
- Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.
- A history of alcohol or drug abuse.
- Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
- Clinically relevant abnormal ECG
- Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).
- Participation within 30 days prior to screening in another investigational study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
naproxcinod
Arm Description
naproxcinod 750mg(375mg caps x2), administered twice a day.
Outcomes
Primary Outcome Measures
To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.
Secondary Outcome Measures
To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.
To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00674856
Brief Title
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
Acronym
HCT3012-X-106
Official Title
A Phase 1 Repeated Dose Open Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750mg Bid Administered to Patients With Impaired Renal Function Compared to Matching Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NicOx
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function
Detailed Description
This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
naproxcinod
Arm Type
Experimental
Arm Description
naproxcinod 750mg(375mg caps x2), administered twice a day.
Intervention Type
Drug
Intervention Name(s)
naproxcinod
Intervention Description
750mg
Primary Outcome Measure Information:
Title
To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.
Time Frame
8 days
Title
To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile.
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.
Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health
Exclusion Criteria:
Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.
A history of alcohol or drug abuse.
Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
Clinically relevant abnormal ECG
Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).
Participation within 30 days prior to screening in another investigational study.
Facility Information:
City
Orlando
State/Province
Florida
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St. Paul
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
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