CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01101919

Enrollment

Registered

2010-04-12

Start date

2010-10-31

Completion date

2010-10-31

Last updated

2011-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Rheumatoid Arthritis

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.

Interventions

DRUGCP-690,550

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Single-dose: Cmax, Tmax, t½, AUCinf and AUClast	1 day
Multiple-dose: Cmin, Cmax, Ctrough, Tmax, t½, AUCtau, and Rac	5 days

Secondary

Measure	Time frame
Number of adverse events and number of participants with adverse events	6 days
Changes in complete blood count and serum chemistry profile	6 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026