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

Phase 1

Completed

• Conditions: Hepatic Insufficiency
• Interventions: Drug: CP-690,550

• Registration Number: NCT00969813
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Study Start: 2009-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-10
• Last Update Posted: 2010-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal hepatic function	CP-690,550	-
Mild hepatic impairment	CP-690,550	-
Moderate hepatic impairment	CP-690,550	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function	3 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function	10-14 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 South Miami, Florida, United States