Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-00232798; Drug: Placebo; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01140425

A7691017

Details and patient eligibility

About

The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.

Enrollment: 44 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• 12-lead ECG demonstrating QTc >450 msec at screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
• History of orthostatic symptoms or orthostatic hypotension at screening.
• Pregnant or nursing females; females of childbearing potential.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 4 patient groups, including a placebo group

PF-00232798 supratherapeutic dose

Experimental group

Description:

PF-00232798 supratherapeutic dose

Treatment:

Drug: PF-00232798

Drug: PF-00232798

PF-00232798 therapeutic dose

Experimental group

Description:

PF-00232798 therapeutic dose

Treatment:

Drug: PF-00232798

Drug: PF-00232798

Placebo for PF-00232798

Placebo Comparator group

Description:

Placebo for PF-00232798

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin

Treatment:

Drug: Moxifloxacin