CP-690,550 Thorough QTc Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-26

Study Completion Date

2008-02-09

Brief Summary

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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.

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Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CP-690,550 100 mg

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Single dose 100 mg (5 x 20 mg tablets)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose placebo tablets (5 tablets)

Moxifloxacin hydrochloride

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Single dose Avelox 400 mg tablet

Interventions

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CP-690,550

Single dose 100 mg (5 x 20 mg tablets)

Intervention Type DRUG

Placebo

Single dose placebo tablets (5 tablets)

Intervention Type DRUG

Moxifloxacin

Single dose Avelox 400 mg tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes