Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00621881
Other study ID # HCT3012-X-105
Secondary ID
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. completion date
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


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
See also
  Status Clinical Trial Phase
Completed NCT02798861 - Controlled Attenuation Parameter (CAP) in Liver Allografts
Completed NCT01968395 - Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure Phase 4
Completed NCT01437969 - Pharmacogenomics Study on IL28B Genetic Variants in Italian Patients With HCV Infection naïve to Treatment.
Recruiting NCT00155376 - Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography Phase 4
Recruiting NCT00172705 - Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique N/A
Completed NCT04185454 - Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese N/A
Completed NCT02506335 - Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Heart Disease Early Phase 1
Completed NCT02520609 - Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
Completed NCT02306018 - Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation N/A
Completed NCT01970904 - Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients N/A
Completed NCT01988753 - Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases
Terminated NCT00741117 - Conjugated Hyperbilirubinemia and Pulse Oximetry N/A
Enrolling by invitation NCT01483248 - Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis Phase 1/Phase 2
Completed NCT00245830 - Ischemic Preconditioning of Liver in Cadaver Donors N/A
Completed NCT00074386 - Kidney and Liver Transplantation in People With HIV N/A
Completed NCT02329821 - Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection N/A
Completed NCT01650181 - Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis Phase 4
Completed NCT01303549 - Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients Phase 4
Completed NCT00799851 - A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices Phase 4
Completed NCT00058890 - Gabapentin to Treat Itch in Patients With Liver Disease Phase 3