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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00979316
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : January 7, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE September 17, 2009
First Posted Date  ICMJE September 18, 2009
Last Update Posted Date January 7, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00979316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects
Official Title  ICMJE Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 in Healthy Subjects
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 Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: BMS-708163
    Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
  • Drug: BMS-708163
    Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
  • Drug: Placebo
    Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days
  • Drug: Moxifloxacin
    Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
    Other Name: Avelox
Study Arms
  • Experimental: BMS-708163 (800 mg)
    Intervention: Drug: BMS-708163
  • Experimental: BMS-708163 (200 mg)
    Intervention: Drug: BMS-708163
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Moxifloxacin
    Intervention: Drug: Moxifloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
62
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2009)
60
Actual Study Completion Date February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00979316
Other Study ID Numbers  ICMJE CN156-020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Study Director, Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP