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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014