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

Primary Purpose

Kidney Diseases

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sorafenib (BAY43-9006, Nexavar)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Diseases

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairment

    Secondary Outcome Measures

    Full Information

    First Posted
    July 8, 2005
    Last Updated
    January 15, 2009
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00119639
    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).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bayer

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Diseases

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Sorafenib (BAY43-9006, Nexavar)
    Intervention Description
    All subjects were given a open-label, single dose of 400mg sorafenib
    Primary Outcome Measure Information:
    Title
    Pharmacokinetics of sorafenib in plasma and urine; single-dose safety of sorafenib in patients with renal impairment
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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