Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/2/2013 |
| Start Date: | May 2012 |
| End Date: | June 2013 |
| Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
| Email: | Clinical.Trials@bms.com |
Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-962476 in Healthy Subjects and in Patients With Hypercholesterolemia on Statin Therapy
To obtain safety and tolerability information in healthy subjects is administered as a
single dose
- Study Classification: Pharmacokinetics and Pharmacodynamics
- Intervention Model: Single Ascending Dose (SAD) study
- Allocation: Randomized Non-Stratified
Inclusion Criteria:
- 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
- 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:
- 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
- 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
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