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Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006

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
Sponsor:
Information provided by:
Bayer

Tracking Information
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
 (submitted: January 15, 2009)
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
Condition  ICMJE Kidney Diseases
Intervention  ICMJE Drug: Sorafenib (BAY43-9006, Nexavar)
All subjects were given a open-label, single dose of 400mg sorafenib
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Sorafenib (BAY43-9006, Nexavar)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2009)
32
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Post menopausal females
  • Surgically sterile females
  • Body Mass Index between 18-37
  • Subjects with Clcr greater than 80 mL/min
  • Subjects with Clcr 50 to 80 mL/min
  • Subjects with Clcr 30 to 50 mL/min
  • Clcr less than 30 mL/min but not on dialysis
  • Subjects must test negative for HIV
  • Subjects must test negative for drugs of abuse at screening

Exclusion Criteria:

All Subjects :

  • Concomitant Medication: Treatment with CYP3A4 inducers, such as rifampin and St. John's Wort within 14 days of Day 1 until they leave the clinic on Day 7
  • Donation of blood within 30 days of Day 1
  • Recent participation in an investigational drug study during which active medication was given within 30 days of Day 1
  • History of gastrointestinal disorder that could result in incomplete absorption of study drug
  • Malignancy
  • Significant neurologic or psychiatric disorders
  • History of drug or alcohol abuse in year prior to screening for this trial, or current intake or >14 standard alcoholic drinks per week
  • Prior history of epilepsy or other seizure disorders
  • Known hypersensitivity to inhibitors of raf kinase or VEGFR-2
  • Females of child-bearing potential
  • Smoking > 10 cigarettes/day or equivalent
  • Excessive consumption (more than five 8-oz. cups/day) of coffee or caffeine

Healthy Volunteer:

  • Existing failure of a major organ system, or a medical disorder that would impair the subject's ability to complete the study (in the opinion of the investigator or the sponsor), eg history of blood coagulation disorders
  • Hematocrit value < 34% in the control group at screening

Renal Impairment Groups:

  • Existing failure of a major organ system or a medical disorder (other than the target disease) which would impair the subject's ability to complete the study (in the opinion of the investigator or the sponsor)
  • Concomitant Medication: Renal impairment subjects taking phosphate binders, ion exchange resins and/or iron supplements may take them with their meals, but must withhold them on the morning of Day 1 (dosing day) until after their 4 hour post-dose tests and procedures are performed.
  • Myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angiography within 6 months of Day 1; unstable angina; uncontrolled significant hypertension within 3 months of Day 1; cerebral vascular accident or transient ischemic attack within 12 months of Day 1
  • Subjects with hypertension who have had a medication or dose change within one week of Day 1
  • Subjects requiring dialysis
  • Subjects with kidney transplants
  • Liver transaminase (AST, ALT) greater than 5 times the ULN at screening; any active liver disease or unexplained or persistent elevations in liver function tests
  • Hematocrit value < 24% in the renal impaired groups
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Bayer Study Director Bayer
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