Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects
A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 On Qt Intervals In Healthy Subjects
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jul 2010
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 23, 2010
December 1, 2010
5 months
June 7, 2010
December 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.
7 days
Secondary Outcomes (4)
QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7
7 days
QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7
7 days
Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast)
7 days
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments
7 days
Study Arms (4)
PF-00232798 supratherapeutic dose
EXPERIMENTALPF-00232798 supratherapeutic dose
PF-00232798 therapeutic dose
EXPERIMENTALPF-00232798 therapeutic dose
Placebo for PF-00232798
PLACEBO COMPARATORPlacebo for PF-00232798
Moxifloxacin
ACTIVE COMPARATORMoxifloxacin
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- ViiV Healthcarecollaborator
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 9, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 23, 2010
Record last verified: 2010-12