Status:
COMPLETED
Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects
Lead Sponsor:
Pfizer
Collaborating Sponsors:
ViiV Healthcare
Conditions:
Healthy
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01140425
Start Date
July 1 2010
End Date
December 1 2010
Last Update
December 23 2010
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770