Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)

NCT ID: NCT00568594

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30

Brief Summary

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

Conditions

Coronary Heart Disease

Keywords

Apolipoprotein A-I,; Atherosclerosis,; HDL,; Inflammation,

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

APL180

Intervention Type: DRUG

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

APL180

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NOVARTIS

Role: PRINCIPAL_INVESTIGATOR

Novartis investigative site

Locations

Novartis Investigator Site

Philadelphia, Pennsylvania, United States

Novartis Investigator Site

Antwerp, , Belgium

Novartis Investigator Site

Birkeroed, , Denmark

Novartis Investigator Site

Jerusalem, , Israel

Novartis Investigator Site

Tel Aviv, , Israel

Novartis Investigator Site

Tzrifin, , Israel

Novartis Investigator Site

Groningen, , Netherlands

Novartis Investigator Site

Bloemfontein, , South Africa

Novartis Investigator Site

George, , South Africa

Novartis Investigator Site

Port Elizabeth, , South Africa

Novartis Investigator Site

Harrow, , United Kingdom

Countries

United States; Belgium; Denmark; Israel; Netherlands; South Africa; United Kingdom

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3320

Results for CAPL180A2201 from the Novartis Clinical Trials website

Other Identifiers

CAPL180A2201

Identifier Type: -

Identifier Source: org_study_id