CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01101919
First received: April 6, 2010
Last updated: November 11, 2011
Last verified: November 2011
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Multiple-dose: Cmin, Cmax, Ctrough, Tmax, t½, AUCtau, and Rac [ Time Frame: 5 days ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01101919     History of Changes
Other Study ID Numbers: A3921065
Study First Received: April 6, 2010
Last Updated: November 11, 2011
Health Authority: China: Food and Drug Adminstration

Keywords provided by Pfizer:
Rheumatoid Arthritis

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

ClinicalTrials.gov processed this record on September 16, 2014