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
  Purpose

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.


Condition Intervention Phase
Hepatic Insufficiency
Drug: CP-690,550
Phase 1

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal hepatic function Drug: CP-690,550
Single 10 mg dose of CP-690,550
Experimental: Mild hepatic impairment Drug: CP-690,550
Single 10 mg dose of CP-690,550
Experimental: Moderate hepatic impairment Drug: CP-690,550
Single 10 mg dose of CP-690,550

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969813

Locations
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00969813     History of Changes
Other Study ID Numbers: A3921015
Study First Received: August 31, 2009
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hepatic impairment

Additional relevant MeSH terms:
Liver Diseases
Hepatic Insufficiency
Digestive System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014