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OpenTrials
Completed

NCT Number: NCT01101919

CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Beijing, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-690,550

Drug

Days 1 and 6 dose of 10 mg once daily Days 2-5 doses of 10 mg twice daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open Label, Single And Multiple Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Healthy Chinese Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 12, 2010
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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