Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects
Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 in Healthy Subjects
1 other identifier
interventional
62
1 country
1
Brief Summary
The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 alzheimer-disease
Started Sep 2009
Shorter than P25 for phase_1 alzheimer-disease
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
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 17, 2009
CompletedFirst Posted
Study publicly available on registry
September 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJanuary 7, 2011
April 1, 2010
5 months
September 17, 2009
January 6, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects
Serial triplicate ECGs at -60, -40 and -20 minutes prior to dosing: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
Secondary Outcomes (1)
To assess the effects of BMS-708163 on other ECG endpoints (heart rate [HR], QRS and PR intervals), and changes in waveform morphology
At -60, -40 and -20 minutes prior to dosing; at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
Study Arms (4)
BMS-708163 (800 mg)
EXPERIMENTALBMS-708163 (200 mg)
EXPERIMENTALPlacebo
PLACEBO COMPARATORMoxifloxacin
ACTIVE COMPARATORInterventions
Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.
- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
- Healthy subjects
You may not qualify if:
- History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
- Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP
- Women who are pregnant or breastfeeding
- History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
- History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- Any clinically significant ECG abnormality
- History of seizure disorders
- History of drowning survival
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mds Pharma Services (Us), Inc
Tempe, Arizona, 85283, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 17, 2009
First Posted
September 18, 2009
Study Start
September 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
January 7, 2011
Record last verified: 2010-04