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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00119639 |
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.
Condition | Intervention | Phase |
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Kidney Diseases |
Drug: Sorafenib (BAY43-9006, Nexavar) |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of Sorafenib (BAY 43-9006, Nexavar). |
Enrollment: | 32 |
Study Start Date: | June 2005 |
Study Completion Date: | December 2005 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Sorafenib (BAY43-9006, Nexavar)
All subjects were given a open-label, single dose of 400mg sorafenib
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Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
All Subjects :
Healthy Volunteer:
Renal Impairment Groups:
Responsible Party: | Bayer Healthcare Pharmaceuticals Inc. ( Head Clinical Pharmacology ) |
Study ID Numbers: | 11804 |
Study First Received: | July 8, 2005 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00119639 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Urologic Diseases Kidney Diseases Protein Kinase Inhibitors Sorafenib |
Molecular Mechanisms of Pharmacological Action Urologic Diseases Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
Kidney Diseases Protein Kinase Inhibitors Sorafenib Pharmacologic Actions |