CP-690,550 Thorough QTc Study

A PHASE 1, RANDOMIZED, PLACEBO- AND POSITIVE-CONTROLLED CROSS-OVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE CP-690,550 ON QTC INTERVAL IN HEALTHY VOLUNTEERS

ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine whether intensive monitoring of QT interval in target patient populations is required during later stages of development. The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation.

The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation

Inclusion Criteria:

• Healthy male and/or female subjects between ages of 18 and 55 years, inclusive.
• Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

• Use of tobacco- or nicotine-containing products in excess of equivalent of 5 cigarettes per day.
• 12-lead ECG demonstrating QTc >450 msec or other clinically significant abnormalities at Screening.
• History of risk factors for QT prolongation or torsades de pointes.
• Pregnant or nursing women; women of childbearing potential unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to first dose until completion of follow-up.
• Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to first dose of trial medication.
• Any clinically significant infections within past 3 months or evidence of infection in past 7 days.