Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function

NCT ID: NCT01740362

Last Updated: 2013-01-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-03-31

Brief Summary

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A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.

Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Healthy volunteers

Group Type OTHER

CP-690,550

Intervention Type DRUG

10 mg (2 x 5 mg tablets), single dose

Mild renal impairment

patients with mild (\>50 and ≤80 mL/min) renal impairment

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

10 mg (2 x 5 mg tablets), single dose

Moderate renal impairment

patients with moderate (≥30 and ≤50 mL/min) renal impairment

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

10 mg (2 x 5 mg tablets), single dose

severe renal impairment

patients with severe (\<30 mL/min) renal impairment

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

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

Intervention Type DRUG

CP-690,550

10 mg (2 x 5 mg tablets), single dose

Intervention Type DRUG

CP-690,550

10 mg (2 x 5 mg tablets), single dose

Intervention Type DRUG

CP-690,550

10 mg (2 x 5 mg tablets), single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance \>80 mL/min
* Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease

Exclusion Criteria

* Kidney transplant patients
* Subjects with any condition possibly affecting drug absorption
* Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Pfizer Investigational Site

New Orleans, Louisiana, United States

Site Status

Pfizer Investigational Site

New Orleans, Louisiana, United States

Site Status

Pfizer Investigational Site

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 24030917 (View on PubMed)

Related Links

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Other Identifiers

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A3921006

Identifier Type: -

Identifier Source: org_study_id

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