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

• ClinicalTrials.gov Identifier: NCT00119639
• Recruitment Status: Completed
• First Posted: July 14, 2005
• Last Update Posted: January 16, 2009
• Sponsor: Bayer
• Information provided by: Bayer

Tracking Information

• First Submitted Date: July 8, 2005
• First Posted Date: July 14, 2005
• Last Update Posted Date: January 16, 2009
• Study Start Date: June 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Kidney Diseases

Intervention

Drug: Sorafenib (BAY43-9006, Nexavar)

All subjects were given a open-label, single dose of 400mg sorafenib

Study Arms

Experimental: Arm 1

Intervention: Drug: Sorafenib (BAY43-9006, Nexavar)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2009): 32
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00119639
• Other Study ID Numbers: 11804
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc.
• Study Sponsor: Bayer
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: January 2009