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Completed

NCT Number: NCT00969813

A Safety and Tolerability Study 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.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-690,550

Drug

Single 10 mg dose of CP-690,550

Primary outcomes

  1. Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function

    Time frame: 3 days

Secondary outcomes

  1. Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function

    Time frame: 10-14 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 1, 2009
Registry last updated
Feb 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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