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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00969813
First received: August 31, 2009
Last updated: February 10, 2010
Last verified: February 2010

August 31, 2009
February 10, 2010
November 2009
January 2010   (final data collection date for primary outcome measure)
Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00969813 on ClinicalTrials.gov Archive Site
Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function [ Time Frame: 10-14 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Hepatic Insufficiency
Drug: CP-690,550
Single 10 mg dose of CP-690,550
  • Experimental: Normal hepatic function
    Intervention: Drug: CP-690,550
  • Experimental: Mild hepatic impairment
    Intervention: Drug: CP-690,550
  • Experimental: Moderate hepatic impairment
    Intervention: Drug: CP-690,550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00969813
A3921015
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP