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NCT00969813 Clinical Trial

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

Hepatic Insufficiency Clinical Trial

Official title:
A Phase 1, Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00969813
Other study ID # A3921015
Secondary ID
Status Completed
Phase Phase 1
First received August 31, 2009
Last updated February 10, 2010
Start date November 2009
Est. completion date January 2010

Study information
Verified date February 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• CP-690,550
Single 10 mg dose of CP-690,550
• CP-690,550
Single 10 mg dose of CP-690,550
• CP-690,550
Single 10 mg dose of CP-690,550

Locations
Country Name City State
United States Pfizer Investigational Site South Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function 3 days No
Secondary Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function 10-14 days Yes
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