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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00969813

Enrollment

Registered

2009-09-01

Start date

2009-11-30

Completion date

2010-01-31

Last updated

2010-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Insufficiency

Keywords

Hepatic impairment

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.

Interventions

DRUGCP-690,550

Single 10 mg dose of CP-690,550

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026