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CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101919
First Posted: April 12, 2010
Last Update Posted: November 16, 2011
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.
Information provided by:
Pfizer
  Purpose
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 Intervention Phase
Healthy Drug: CP-690,550 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Estimated Enrollment: 12
Study Start Date: October 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01101919


Locations
China
Pfizer Investigational Site
Beijing, China, 100032
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01101919     History of Changes
Other Study ID Numbers: A3921065
First Submitted: April 6, 2010
First Posted: April 12, 2010
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by Pfizer:
Rheumatoid Arthritis

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