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

This study is currently recruiting participants.
Verified by Novartis, June 2008

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00568594
  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


Condition Intervention Phase
Coronary Heart Disease (CHD)
Drug: APL180
Drug: Placebo
Phase I
Phase II

MedlinePlus related topics:   Heart Diseases   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title:   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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Pharmacokinetic/pharmacodynamic relationship after a single and 7 daily infusions in CHD patients [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:   120
Study Start Date:   November 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   March 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator Drug: APL180
2: Placebo Comparator Drug: Placebo

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568594

Contacts
Contact: NOVARTIS     +41 61 324 1111    

Locations
United States, Pennsylvania
Novartis Investigator Site     Recruiting
      Philadelphia, Pennsylvania, United States
      Contact: Novartis     862-778-8300        
Belgium
Novartis Investigator Site     Recruiting
      Antwerp, Belgium
      Contact     +41 61 324 1111        
Novartis Investigator Site     Recruiting
      Leuven, Belgium
      Contact: Novartis     +41 61 324 1111        
Denmark
Novartis Investigator Site     Recruiting
      Birkenrod, Denmark
      Contact: Novartis     +41 61 324 1111        
Israel
Novartis Investigator Site     Recruiting
      Tel-Aviv, Israel
      Contact: Novartis     +41 61 324 1111        
Netherlands
Novartis Investigator Site     Recruiting
      Groningen, Netherlands
      Contact     +41 61 324 1111        
South Africa
Novartis Investigator Site     Recruiting
      Bloemfontein, South Africa
      Contact: Novartis     +41 61 324 1111        
United Kingdom
Novartis Investigator Site     Recruiting
      Harrow, United Kingdom
      Contact     +41 61 324 1111        

Sponsors and Collaborators
Novartis

Investigators
Principal Investigator:     NOVARTIS     Novartis investigative site    
  More Information

Responsible Party:   Novartis ( External Affairs )
Study ID Numbers:   CAPL180A2201
First Received:   December 5, 2007
Last Updated:   June 17, 2008
ClinicalTrials.gov Identifier:   NCT00568594
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:
apolipoprotein A-I, atherosclerosis, HDL, inflammation, peptide mimetics  

Study placed in the following topic categories:
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Healthy
Ischemia
Inflammation

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2008




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