CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

NCT ID: NCT01101919

Last Updated: 2011-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CP-690,550 Dose Group

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

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

Interventions

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CP-690,550

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Beijing, , China

Site Status

Countries

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China

References

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Krishnaswami S, Wang T, Yuan Y, Alvey CW, Checchio T, Peterson M, Shi H, Riese R. Single- and multiple-dose pharmacokinetics of tofacitinib in healthy Chinese volunteers. Clin Pharmacol Drug Dev. 2015 Sep;4(5):395-9. doi: 10.1002/cpdd.202. Epub 2015 Jul 16.

Reference Type DERIVED
PMID: 27137149 (View on PubMed)

Related Links

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Other Identifiers

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A3921065

Identifier Type: -

Identifier Source: org_study_id