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Completed

NCT Number: NCT00979316

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

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mds Pharma Services (Us), Inc

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-708163

Drug

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

Placebo

Drug

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

moxifloxacin

Drug

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

Other names: Avelox

Primary outcomes

  1. Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 18, 2009
Registry last updated
Jan 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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