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Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)
This study has been completed.
Study NCT00568594   Information provided by Novartis
First Received: December 5, 2007   Last Updated: October 2, 2009   History of Changes

December 5, 2007
October 2, 2009
November 2007
September 2009   (final data collection date for primary outcome measure)
Safety and tolerability, pharmacokinetics and effects on biomarkers of HDL function of APL180 after a single and 7-daily infusions in healthy volunteers (HV) and in patients with coronary heart disease (CHD) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00568594 on ClinicalTrials.gov Archive Site
Pharmacokinetic/pharmacodynamic relationship after a single and 7 daily infusions in CHD patients [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Same as current
 
Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)
A First-in-human, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose (Healthy Volunteers and CHD Patients) and Multiple Dose (CHD Patients) Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

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

 
Phase I, Phase II
Interventional
Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Coronary Heart Disease
  • Drug: APL180
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
176
 
September 2009   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Denmark,   Israel,   Netherlands,   South Africa,   United Kingdom
 
NCT00568594
External Affairs, Novartis
CAPL180A2201
Novartis
 
Principal Investigator: NOVARTIS Novartis investigative site
Novartis
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP