Safety Study of BMS-844421 for Treatment of Hypercholesterolemia
NCT ID: NCT01082562
Last Updated: 2011-01-26
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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TERMINATED
PHASE1
40 participants
INTERVENTIONAL
2010-04-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Arm 1 - BMS-844421
BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 2 - 0.9% sodium chloride injection solution
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 3 - BMS-844421
BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 4 - 0.9% sodium chloride injection solution
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 5 - BMS-844421
BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 6 - 0.9% sodium chloride injection solution
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 7 - BMS-844421
BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 8 - 0.9% sodium chloride injection solution
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 9 - BMS-844421
BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 10 - 0.9% sodium chloride injection solution
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 11 - BMS-844421
BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 12 - 0.9% sodium chloride injection solution
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 13 - BMS-844421
BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 14 - 0.9% sodium chloride injection solution
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 15 - BMS-844421
BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Arm 16 - 0.9% sodium chloride injection solution
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Interventions
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BMS-844421
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
0.9% sodium chloride injection solution
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
Eligibility Criteria
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Inclusion Criteria
* Healthy Subjects (MAD) with untreated elevated cholesterol
* Body Mass Index (BMI) of 18 to 30 kg/m² inclusive
* Women who are not of childbearing potential and men, ages 18 to 45
Exclusion Criteria
* History of liver or renal disorders
* Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration
18 Years
45 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Berlin, , Germany
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2009-012032-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV198-002
Identifier Type: -
Identifier Source: org_study_id
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