CP-690,550 Thorough QTc Study

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: CP-690,550

Drug: Moxifloxacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01743677

A3921028

2007-004492-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.