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

Alzheimer Disease Clinical Trial

Official title:

Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979316
• Other study ID #: CN156-020
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2009
• Last updated: January 6, 2011
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• BMS-708163
Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
• BMS-708163
Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
• Placebo
Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days
• Moxifloxacin
Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days

Locations

Country	Name	City	State
United States	Mds Pharma Services (Us), Inc	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form