Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
NCT ID: NCT01740362
Last Updated: 2013-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2003-10-31
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Healthy volunteers
Healthy volunteers
CP-690,550
10 mg (2 x 5 mg tablets), single dose
Mild renal impairment
patients with mild (\>50 and ≤80 mL/min) renal impairment
CP-690,550
10 mg (2 x 5 mg tablets), single dose
Moderate renal impairment
patients with moderate (≥30 and ≤50 mL/min) renal impairment
CP-690,550
10 mg (2 x 5 mg tablets), single dose
severe renal impairment
patients with severe (\<30 mL/min) renal impairment
CP-690,550
10 mg (2 x 5 mg tablets), single dose
Interventions
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CP-690,550
10 mg (2 x 5 mg tablets), single dose
CP-690,550
10 mg (2 x 5 mg tablets), single dose
CP-690,550
10 mg (2 x 5 mg tablets), single dose
CP-690,550
10 mg (2 x 5 mg tablets), single dose
Eligibility Criteria
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Inclusion Criteria
* Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease
Exclusion Criteria
* Subjects with any condition possibly affecting drug absorption
* Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin
18 Years
65 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Countries
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References
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Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921006
Identifier Type: -
Identifier Source: org_study_id
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