NCT01101919CompletedPhase 1
An Open Label, Single And Multiple Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Healthy Chinese Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Single-dose: Cmax, Tmax, t½, AUCinf and AUClast
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
CP-690,550 Dose Group
Experimental
Intervention: CP-690,550 (Drug)
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(6 days)
- Changes in complete blood count and serum chemistry profile(6 days)
Investigators
Study Sites (1)
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