CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

Phase 1CompletedNCT01101919

Pfizer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CP-690,550DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Beijing, China

Outcomes

Primary Outcomes

Single-dose: Cmax, Tmax, t½, AUCinf and AUClast

Time frame: 1 day

Multiple-dose: Cmin, Cmax, Ctrough, Tmax, t½, AUCtau, and Rac

Time frame: 5 days

Secondary Outcomes

Number of adverse events and number of participants with adverse events

Time frame: 6 days

Changes in complete blood count and serum chemistry profile

Time frame: 6 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.