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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00979316
First received: September 17, 2009
Last updated: January 6, 2011
Last verified: April 2010
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979316

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Moxifloxacin
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

ClinicalTrials.gov processed this record on July 20, 2014