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

Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621881
• Other study ID #: HCT3012-X-105
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2008
• Last updated: June 16, 2011
• Start date: January 2008

Study information

• Verified date: June 2011
• Source: NicOx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Drug:
• naproxcinod
750 mg bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NicOx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes