Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00119639 |
Recruitment Status :
Completed
First Posted : July 14, 2005
Last Update Posted : January 16, 2009
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Sponsor:
Bayer
Information provided by:
Bayer
Tracking Information | ||||
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First Submitted Date ICMJE | July 8, 2005 | |||
First Posted Date ICMJE | July 14, 2005 | |||
Last Update Posted Date | January 16, 2009 | |||
Study Start Date ICMJE | June 2005 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairment [ Time Frame: 2 weeks ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006 | |||
Official Title ICMJE | A Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of Sorafenib (BAY 43-9006, Nexavar). | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Kidney Diseases | |||
Intervention ICMJE | Drug: Sorafenib (BAY43-9006, Nexavar)
All subjects were given a open-label, single dose of 400mg sorafenib
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Study Arms ICMJE | Experimental: Arm 1
Intervention: Drug: Sorafenib (BAY43-9006, Nexavar)
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
32 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | December 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: All Subjects :
Healthy Volunteer:
Renal Impairment Groups:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00119639 | |||
Other Study ID Numbers ICMJE | 11804 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc. | |||
Study Sponsor ICMJE | Bayer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bayer | |||
Verification Date | January 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |