Trials / Completed
CompletedNCT01370148
A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
A Phase 1, Open-Label Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Cumberland Pharmaceuticals · Industry
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.
Detailed description
Subjects will be admitted to the Phase 1 unit Day -2 and will remain confined to the unit until discharge on Study Day 5 after completion of all study procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | conivaptan hydrochloride | Intravenous |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2011-06-09
- Last updated
- 2014-05-02
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01370148. Inclusion in this directory is not an endorsement.