Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins
NCT ID: NCT01587365
Last Updated: 2013-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2012-05-31
2013-05-31
Brief Summary
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Detailed Description
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* Intervention Model: Single Ascending Dose (SAD) study
* Allocation: Randomized Non-Stratified
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Panel 1: BMS-962476 SC (0.01 mg/Kg) or Placebo
BMS-962476 0.01 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
BMS-962476
Placebo matching with BMS-962476
Panel 2: BMS-962476 SC (0.03 mg/Kg) or Placebo
BMS-962476 0.03 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
BMS-962476
Placebo matching with BMS-962476
Panel 3: BMS-962476 SC (0.1 mg/Kg) or Placebo
BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
BMS-962476
Placebo matching with BMS-962476
Panel 4: BMS-962476 SC (0.3 mg/Kg) or Placebo
BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
BMS-962476
Placebo matching with BMS-962476
Panel 5: BMS-962476 IV (0.3 mg/Kg) or Placebo
BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day
BMS-962476
Placebo matching with BMS-962476
Panel 6: BMS-962476 IV (1.0 mg/Kg) or Placebo
BMS-962476 1.0 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day
BMS-962476
Placebo matching with BMS-962476
Panel 7: Statin + BMS-962476 SC (0.1 mg/Kg) or Placebo
BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
BMS-962476
Placebo matching with BMS-962476
Panel 8: Statin + BMS-962476 SC (0.3 mg/Kg) or Placebo
BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
BMS-962476
Placebo matching with BMS-962476
Interventions
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BMS-962476
Placebo matching with BMS-962476
Eligibility Criteria
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Inclusion Criteria
* Untreated low density lipoprotein cholesterol (LDL-c) ≥ 130 and ≤ 190 mg/dL and triglycerides ≤ 200 mg/dL
* Body Mass Index (BMI) of 18 to 35 kg/m2 inclusive
* Men and women, ages 18 to 65 years, inclusive
* Statin population
* Patients with hypercholesterolemia on stable statin therapy for 6 weeks prior to enrollment
* At enrollment, LDL-c ≥ 100mg/dL and triglycerides ≤ 200 mg/dL
* Patients with controlled hypertension on a stable dose of no more than two antihypertensive drugs
* BMI of 18 to 37 kg/m2 inclusive
* Men and women, ages 18 to 75 years inclusive
Exclusion Criteria
* Subjects with fasting LDL-c \< 130 or \> 190 mg/dL, or fasting triglycerides \> 200 mg/dL
* Subjects at increased 10-year cardiovascular risk of ≥ 20% based on Framingham risk score
* Subjects with any significant acute or chronic medical illness at the time of screening, including history of cancer, known history of sickle cell disease or trait, and known history of thalassemia
* Statin population
* Patients with fasting LDL-c \< 100mg/dL, or fasting triglycerides \> 200 mg/dL on statin therapy
* Patients on prescription or over the counter lipid-lowering therapy other than statin therapy
* Patients with established atherosclerotic vascular disease
* Patients with diabetes who are requiring oral or injectable anti-diabetic drug therapy
* Patients with uncontrolled hypertension or controlled hypertension requiring more than two antihypertensive drugs
* Patients with any significant acute or chronic medical illness that is severe, progressive or uncontrolled at the time of screening
* Use of any lipid lowering medication including over the counter products (eg, niacin \> 500 mg; omega-3 fatty acids \> 1000 mg; red rice yeast; phytosterols or stanol esters) for lipid lowering within 30 days prior to screening visit (42 days for fibrates) with the exception of stable statin therapy in the target disease population
* Prior treatment with any monoclonal antibody or investigational protein biologic within the preceding one year before study drug administration
* Concurrent or use within 3 months of study drug administration of marketed or investigational systemic or inhaled corticosteroids or other immunosuppressant drugs, and within 6 weeks for topical corticosteroids
18 Years
65 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Metabolic And Atherosclerosis Research Center/ Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CV206-001
Identifier Type: -
Identifier Source: org_study_id