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A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
NicOx
ClinicalTrials.gov Identifier:
NCT00621881
First received: February 12, 2008
Last updated: June 16, 2011
Last verified: June 2011
History of Changes
  Purpose

This is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.


Condition Intervention Phase
Liver Disease
 Drug: naproxcinod
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by NicOx:

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

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. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: January 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
750 mg naproxcinod
 Drug: naproxcinod
750 mg bid

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621881

Locations
United States, Florida
Miami, Florida, United States
Sponsors and Collaborators
NicOx
  More Information

No publications provided

Responsible Party: Dr Brigitte Duquesroix, Senior Director of Clinical Research, nicox
ClinicalTrials.gov Identifier: NCT00621881     History of Changes
Other Study ID Numbers: HCT3012-X-105
Study First Received: February 12, 2008
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by NicOx:
hepatic impairment

Additional relevant MeSH terms:
Liver Diseases
Digestive System 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 21, 2013