Trials / Completed
CompletedNCT00621881
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- NicOx · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | naproxcinod | 750 mg bid |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2008-04-01
- First posted
- 2008-02-22
- Last updated
- 2011-06-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00621881. Inclusion in this directory is not an endorsement.