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Completed

NCT Number: NCT00621881

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

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

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Key information

Conditions

Liver Disease Digestive System Diseases Liver Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naproxcinod

Drug

750 mg bid

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

    Time frame: 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.

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

NicOx

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
First posted
Feb 22, 2008
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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