Status:
COMPLETED
Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006
Lead Sponsor:
Bayer
Conditions:
Kidney Diseases
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
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, moder...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00119639
Start Date
June 1 2005
End Date
December 1 2005
Last Update
January 16 2009
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