check_circleStudy Completed
Kidney Diseases
Bayer Identifier:
11804
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study to Evaluate the Effect of Renal Function on the Single-dose Pharmacokinetics of BAY43-9006
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
40 - 75 YearsTrial summary
Enrollment Goal
32Trial Dates
June 2005 - December 2005Phase
Phase 1Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoPrimary Outcome
- Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairmentdate_rangeTime Frame:2 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1