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Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease

NCT ID: NCT01710020

Last Updated: 2012-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-06-30

Brief Summary

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There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a second period (Period 2) will be conducted. In Period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.

Detailed Description

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Conditions

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End-Stage Renal Disease Hemodialysis

Keywords

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CP-690 550 pharmacokinetics end-stage renal disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CP-690,550

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 10 mg oral powder for constitution

Interventions

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CP-690,550

CP-690,550 10 mg oral powder for constitution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with end-stage renal disease
* Subjects need hemodialysis 3 times weekly

Exclusion Criteria

* Subjects with evidence or history of clinically significant disease, excluding those common for subjects with End-Stage Renal Disease (ESRD).
* 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

No

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

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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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921004&StudyName=Pharmacokinetics%20And%20Dialysability%20Of%20CP-690%2C550%20In%20Subjects%20With%20End-Stage%20Renal%20Disease

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Other Identifiers

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A3921004

Identifier Type: -

Identifier Source: org_study_id