Overview
Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects
Status:
Completed
Completed
Trial end date:
2010-12-01
2010-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
PfizerCollaborator:
ViiV HealthcareTreatments:
Fluoroquinolones
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
PF 232798
Criteria
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.