NCT00621881

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Last Updated

June 17, 2011

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

February 12, 2008

Last Update Submit

June 16, 2011

Conditions

Liver Disease

Keywords

hepatic impairment

Outcome Measures

Primary Outcomes (1)

  • 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

    8 days

Secondary Outcomes (1)

  • To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects.

    8 days

Study Arms (1)

1

EXPERIMENTAL

750 mg naproxcinod

Drug: naproxcinod

Interventions

naproxcinodDRUG

750 mg bid

1

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

naproxen-n-butyl nitrate

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Last Updated

June 17, 2011

Record last verified: 2011-06

Locations

US(1)