check_circleStudy Completed

Kidney Diseases

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

Both

Age

40 - 75 Years

Trial summary

Enrollment Goal
32
Trial Dates
June 2005 - December 2005
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Primary Outcome

  • Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairment
    date_rangeTime Frame:
    2 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A study to evaluate the Effect of Renal Function on the Single-dose Pharmacokinetics of Sorafenib (BAY43-9006, Nexavar).
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1