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A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function (HCT3012-X-106)

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ClinicalTrials.gov Identifier: NCT00674856
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : January 28, 2009
Sponsor:
Information provided by:
NicOx

Brief Summary:
To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

Condition or disease Intervention/treatment Phase
Renal Failure Drug: naproxcinod Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Arm Intervention/treatment
Experimental: naproxcinod
naproxcinod 750mg(375mg caps x2), administered twice a day.
Drug: naproxcinod
750mg



Primary Outcome Measures :
  1. 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 Measures :
  1. To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects. [ Time Frame: 8 days ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674856


Locations
United States, Florida
Orlando, Florida, United States
United States, Minnesota
Minneapolis, Minnesota, United States
St. Paul, Minnesota, United States
Sponsors and Collaborators
NicOx

Responsible Party: NicOx, NicOx.
ClinicalTrials.gov Identifier: NCT00674856     History of Changes
Other Study ID Numbers: HCT 3012-X-106
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Naproxen-n-butyl nitrate
Naproxen
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors