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

NicOx24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Liver Disease

Interventions

naproxcinodDRUG

750 mg bid

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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