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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00979316

Enrollment

Registered

2009-09-18

Start date

2009-09-30

Completion date

2010-02-28

Last updated

2011-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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).

Interventions

DRUGBMS-708163

Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days

DRUGPlacebo

Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days

DRUGMoxifloxacin

Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026