Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins
Status and phase
Conditions
Treatments
Details and patient eligibility
About
To obtain safety and tolerability information in healthy subjects is administered as a single dose
Full description
- Study Classification: Pharmacokinetics and Pharmacodynamics
- Intervention Model: Single Ascending Dose (SAD) study
- Allocation: Randomized Non-Stratified
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Healthy population
- 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
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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
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Healthy Population
- 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
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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
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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
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Prior treatment with any monoclonal antibody or investigational protein biologic within the preceding one year before study drug administration
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
66 participants in 8 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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