Expired Study
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Philadelphia, Pennsylvania


Purpose:

The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180 administered as a single intravenous infusion in healthy volunteers, and (2) the safety, pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of APL018 in patients with CHD


Criteria:

Inclusion Criteria: - Male and female healthy volunteers (ages 18-55 years) and patients with CHD (ages 18 to 75 years) on stable statin therapy for at least 8 weeks, with normal liver and kidney function. - Women who are post-menopausal, surgically sterile, or practicing effective contraception. Additional birth control details to be provided at screening. - Body mass index (BMI) must be within the range of 20 to 35 for CHD patients or CHD equivalents. - Clinical CHD: - Myocardial infarction (MI), angina, revascularization (e.g. CABG, stent) at least 6 months prior to inclusion - CHD equivalents: - symptomatic carotid artery disease (e.g. transient ischemic attack or stroke of carotid origin) or peripheral artery disease or abdominal aortic aneurysm or Diabetes Mellitus (HbA1c ≤9) - 20% 10 year risk of CHD (Framingham point score: ≥16 (men), ≥23 (women)) - Other clinical forms of atherosclerotic disease including >50 percent stenosis on angiography or ultrasound - Male subjects, when sexually active, using one form of highly effective contraception (e.g. condom) Exclusion Criteria for both healthy volunteers and patients: - Smokers (use of tobacco products in the previous 3 months). Smokers who report cigarette use of more then 10 cigarette per day or have a urinary cotinine level greater then 500 ng/ml. - Pregnancy. - Use of any prescription drugs within four (4) weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two (2) weeks prior to dosing. Significant illness within two weeks prior to dosing. - Significant illness within two weeks prior to dosing. - A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome. - History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug or any allergic reaction to prior receipt of protein therapies or vaccines. - Presence of NYHA Class III or IV CHF or unstable angina pectoris. - MI or within angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to dosing. - Use of certain medications prohibited by the protocol. - Uncontrolled diabetes (HbA1c > 9). - Uncontrolled hypertension (Systolic BP >160 mm Hg and/or Diastolic BP >100 mmHg on two consecutive measurements). - Liver or kidney disease confirmed by abnormal lab values or function. - Serum creatine kinase CK (CPK) total > 2x. - CHD equivalent patients with a history of early positive exercise stress test. Other protocol-defined inclusion/exclusion criteria may apply


NCT ID:

NCT00568594


Primary Contact:

Principal Investigator
NOVARTIS
Novartis investigative site


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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