CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CP-690,550

• Registration Number: NCT01101919
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-12
• Study Start: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-11
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CP-690,550 Dose Group	CP-690,550	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Beijing, China