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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Placebo; Drug: Moxifloxacin; Drug: BMS-708163

• Registration Number: NCT00979316
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-04
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Moxifloxacin	Moxifloxacin	-
BMS-708163 (800 mg)	BMS-708163	-
BMS-708163 (200 mg)	BMS-708163	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mds Pharma Services (Us), Inc; 🇺🇸 Tempe, Arizona, United States