Trial record 6 of 13 for:    "BMS-708163"

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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: September 17, 2009
Last updated: January 6, 2011
Last verified: April 2010

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

Condition Intervention Phase
Alzheimer Disease
Drug: BMS-708163
Drug: Placebo
Drug: Moxifloxacin
Phase 1

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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-708163 (800 mg) Drug: BMS-708163
Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
Experimental: BMS-708163 (200 mg) Drug: BMS-708163
Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
Placebo Comparator: Placebo Drug: Placebo
Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days
Active Comparator: Moxifloxacin Drug: Moxifloxacin
Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
Other Name: Avelox


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00979316

United States, Arizona
Mds Pharma Services (Us), Inc
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00979316     History of Changes
Other Study ID Numbers: CN156-020
Study First Received: September 17, 2009
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 15, 2014