Trials / Completed
CompletedNCT00119639
Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006
A Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of Sorafenib (BAY 43-9006, Nexavar).
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a 400 mg (2 x 200 mg tablets) sorafenib single dose, open-label study being conducted to compare the pharmacokinetics of plasma and urine and safety of sorafenib in subjects with severe, moderate, and mild renal impairment with those exhibiting normal renal function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib (BAY43-9006, Nexavar) | All subjects were given a open-label, single dose of 400mg sorafenib |
Timeline
- Start date
- 2005-06-01
- Completion
- 2005-12-01
- First posted
- 2005-07-14
- Last updated
- 2009-01-16
Source: ClinicalTrials.gov record NCT00119639. Inclusion in this directory is not an endorsement.