- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00979316
Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects
January 6, 2011 updated by: Bristol-Myers Squibb
Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- MDS Pharma Services (US), Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days
|
Active Comparator: Moxifloxacin
|
Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
Other Names:
|
Experimental: BMS-708163 (800 mg)
|
Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
|
Experimental: BMS-708163 (200 mg)
|
Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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 Outcome Measures
Outcome 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
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
September 17, 2009
First Submitted That Met QC Criteria
September 17, 2009
First Posted (Estimate)
September 18, 2009
Study Record Updates
Last Update Posted (Estimate)
January 7, 2011
Last Update Submitted That Met QC Criteria
January 6, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Moxifloxacin
Other Study ID Numbers
- CN156-020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on BMS-708163
-
Bristol-Myers SquibbCompletedHealthy | Alzheimer's DiseaseUnited States
-
Bristol-Myers SquibbCompletedAlzheimer's DiseaseUnited States
-
Bristol-Myers SquibbCompleted
-
Bristol-Myers SquibbCompletedAlzheimer's DiseaseSweden, United States, Denmark, Finland
-
Bristol-Myers SquibbTerminatedAlzheimer's DiseaseSweden, United States, Canada, Denmark, France, Finland
-
Bristol-Myers SquibbCompletedAlzheimer's Disease
-
Bristol-Myers SquibbCompleted
-
Bristol-Myers SquibbCompleted
-
Bristol-Myers SquibbCompleted
-
Bristol-Myers SquibbCompletedAlzheimer DiseaseUnited States