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A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function

NCT ID: NCT00969813

Last Updated: 2010-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-01-31

Brief Summary

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This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.

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Detailed Description

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Conditions

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Hepatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Normal hepatic function

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Single 10 mg dose of CP-690,550

Mild hepatic impairment

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Single 10 mg dose of CP-690,550

Moderate hepatic impairment

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Single 10 mg dose of CP-690,550

Interventions

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CP-690,550

Single 10 mg dose of CP-690,550

Intervention Type DRUG

CP-690,550

Single 10 mg dose of CP-690,550

Intervention Type DRUG

CP-690,550

Single 10 mg dose of CP-690,550

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment.

Exclusion Criteria

* Subjects with severe liver impairment
* Subjects who have weakened immune systems
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

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

South Miami, Florida, United States

Site Status

Countries

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United States

References

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Lawendy N, Lamba M, Chan G, Wang R, Alvey CW, Krishnaswami S. The effect of mild and moderate hepatic impairment on the pharmacokinetics of tofacitinib, an orally active Janus kinase inhibitor. Clin Pharmacol Drug Dev. 2014 Nov;3(6):421-7. doi: 10.1002/cpdd.143. Epub 2014 Oct 1.

Reference Type DERIVED
PMID: 27129117 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921015&StudyName=A%20Safety%20and%20Tolerability%20Study%20of%20CP-690%2C550%20in%20Subjects%20with%20Hepatic%20Impairment%20and%20Normal%20Hepatic%20Function

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3921015

Identifier Type: -

Identifier Source: org_study_id

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