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

ID: NCT00119639
Status: Completed
Phase: Phase 1
Start Date: June 01, 2005
First Submitted: July 08, 2005
Last Updated: January 15, 2009
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: N/A
Conditions: Kidney Diseases
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Study Description

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

Condition or disease Intervention/treatment Phase

Kidney Diseases

Drug: Sorafenib (BAY43-9006, Nexavar)
Other Names
Phase 1

Tracking Information

First Submitted DateJuly 08, 2005
Last Update Posted DateJanuary 15, 2009
Start DateJune 01, 2005
Actual Completion DateDecember 01, 2005
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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 Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006
Official TitleA 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

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
32
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None
Primary Purpose
Basic Science
Conditions
Kidney Diseases
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Sorafenib (BAY43-9006, Nexavar)

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

Other Names
Study Groups/Cohorts
Arm 1

Study Arms
Experimental Arm 1
Drug : Sorafenib (BAY43-9006, Nexavar)
All subjects were given a open-label, single dose of 400mg sorafenib

Arm Intervention/Treatment
Experimental Arm 1
Drug : Sorafenib (BAY43-9006, Nexavar)

Recruitment Information

Recruitment Status:Completed
Enrollment32
Completion DateDecember 01, 2005
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
GenderAll
Age40 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00119639
Other Study ID Numbers
11804
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyHead Clinical Pharmacology,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer