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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00621881

Enrollment

Registered

2008-02-22

Start date

2008-01-31

Completion date

Unknown

Last updated

2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

hepatic impairment

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.

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.

Interventions

DRUGnaproxcinod

750 mg bid

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026