Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers

Pfizer12 enrolled

Overview

This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CP-690,550DRUG

Single doses separated by a minimum of 72 hour washout between treatments

Eligibility

Sex: ALLMin age: 21 MonthsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and/or female subjects Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * Clinically significant infections within the past 3 months.

Locations (1)

Pfizer Investigational Site

Singapore, Singapore

Outcomes

Primary Outcomes

Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550

Time frame: 36 hours

Secondary Outcomes

Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550

Time frame: 9 days

Safety: laboratory tests, adverse events reporting, ECG and vital signs

Time frame: 9 days

Data from ClinicalTrials.gov

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