Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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