CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101919
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : November 16, 2011
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Brief Summary:
This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese subjects following both single doses and multiple doses of drug.

Condition or disease Intervention/treatment Phase
Healthy Drug: CP-690,550 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single And Multiple Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Healthy Chinese Subjects
Study Start Date : October 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CP-690,550 Dose Group Drug: CP-690,550
Days 1 and 6 dose of 10 mg once daily Days 2-5 doses of 10 mg twice daily

Primary Outcome Measures :
  1. Single-dose: Cmax, Tmax, t½, AUCinf and AUClast [ Time Frame: 1 day ]
  2. Multiple-dose: Cmin, Cmax, Ctrough, Tmax, t½, AUCtau, and Rac [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Number of adverse events and number of participants with adverse events [ Time Frame: 6 days ]
  2. Changes in complete blood count and serum chemistry profile [ Time Frame: 6 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy Chinese Volunteers
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

  • Clinically significant infections within the past 3 months
  • Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus
  • Pregnant or nursing women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01101919

Pfizer Investigational Site
Beijing, China, 100032
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01101919     History of Changes
Other Study ID Numbers: A3921065
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by Pfizer:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action