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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
South Miami, Florida, 33143 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatic Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy volunteers who have normal liver function, and subjects who have either mild
or moderate liver impairment.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with severe liver impairment

- Subjects who have weakened immune systems

NCT00969813
Pfizer
Completed
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function

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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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00969813
A3921015
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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