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

This study has been completed.
Sponsor:
Information provided by:
NicOx
ClinicalTrials.gov Identifier:
NCT00674856
First received: May 6, 2008
Last updated: January 27, 2009
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Renal Failure
 Drug: naproxcinod
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by NicOx:

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. [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: naproxcinod
naproxcinod 750mg(375mg caps x2), administered twice a day.
 Drug: naproxcinod
750mg

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: NicOx, NicOx.
ClinicalTrials.gov Identifier: NCT00674856     History of Changes
Other Study ID Numbers: HCT 3012-X-106
Study First Received: May 6, 2008
Last Updated: January 27, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Naproxen-n-butyl nitrate
Naproxen
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013