Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
NCT ID: NCT00717067
Last Updated: 2010-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2008-07-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Healthy Subjects
Subjects with Normal Renal Function (Creatinine Clearance \> 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir
Maraviroc
Maraviroc 300 mg (150 mg x 2 tablets) x single dose
Maraviroc
Maraviroc 150 mg tablet twice daily x 7 days
Ritonavir
Ritonavir 100 mg capsule twice daily x 7 days
Saquinavir
Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
Mild Renal Impairment
Subjects with Mild Renal Impairment (Creatinine Clearance \>50 and ≤80 mL/min)
Maraviroc
Maraviroc 150 mg tablet once daily x 7 days
Ritonavir
Ritonavir 100 mg capsule twice daily x 7 days
Saquinavir
Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
Moderate Renal Impairment
Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
Maraviroc
Maraviroc 150 mg tablet once every 48 hours x 7 days
Ritonavir
Ritonavir 100 mg capsule twice daily x 7 days
Saquinavir
Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
Severe Renal Impairment
Subjects with Severe Renal Impairment (Creatinine Clearance \<30 mL/min)
Maraviroc
Maraviroc 300 mg (150 mg x 2 tablets) x single dose
ESRD on Hemodialysis
Subjects with End Stage Renal Impairment receiving Hemodialysis(Creatinine Clearance \<30 mL/min) (I) Maraviroc single dose one hour following completion of hemodialysis, followed by (II) Maraviroc single dose three hours prior to start of hemodialysis
Maraviroc
Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis
Maraviroc
Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis
Interventions
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Maraviroc
Maraviroc 300 mg (150 mg x 2 tablets) x single dose
Maraviroc
Maraviroc 150 mg tablet twice daily x 7 days
Ritonavir
Ritonavir 100 mg capsule twice daily x 7 days
Saquinavir
Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
Maraviroc
Maraviroc 150 mg tablet once daily x 7 days
Ritonavir
Ritonavir 100 mg capsule twice daily x 7 days
Saquinavir
Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
Maraviroc
Maraviroc 150 mg tablet once every 48 hours x 7 days
Ritonavir
Ritonavir 100 mg capsule twice daily x 7 days
Saquinavir
Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
Maraviroc
Maraviroc 300 mg (150 mg x 2 tablets) x single dose
Maraviroc
Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis
Maraviroc
Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive.
* Total body weight \>50 kg (110 lbs).
* Male or female subjects between the ages of 18 and 85 years.
Exclusion Criteria
* Supine BP at Screening ≥160 mm Hg systolic or ≥95 mm Hg diastolic.
* Supine BP at Screening ≤80 mm Hg systolic or ≤40 mm Hg diastolic.
18 Years
85 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
München, , Germany
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4001075
Identifier Type: -
Identifier Source: org_study_id