Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

Study Description

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Brief Summary:

The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease	Drug: APL180; Drug: Placebo	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	104 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Basic Science
Official Title:	A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study in Patients With Coronary Heart Disease (CHD) to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of APL180
Study Start Date :	June 2009
Actual Primary Completion Date :	October 2009

Arms and Interventions

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Arm	Intervention/treatment
Experimental: APL180 (first dose level)	Drug: APL180
Experimental: APL180 (second dose level)	Drug: APL180
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

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Primary Outcome Measures :

1. Safety and tolerability of APL180 [ Time Frame: Throughout the study ]

Secondary Outcome Measures :

1. Pharmacokinetics of APL180 [ Time Frame: Throughout the study ]
2. Evaluate effects of APL180 biomarkers [ Time Frame: Throughout the study ]
3. Pharmacokinetic-pharmacodynamic relationship of APL180 [ Time Frame: Throughout the study ]
4. Effect of APL180 on exploratory biomarkers, [ Time Frame: Throughout the study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male and female CHD or CHD equivalent patients
• Body mass index (BMI) must be within the range of 20 to 35 kg/m2,
• Patient must have been on a stable statin therapy for >8 weeks prior to first dose except for the statin intolerant patients.

Exclusion criteria:

• Pregnancy
• Significant illness within two weeks prior to dosing.
• Triglycerides ≥ 500 mg/dl (5.65 mmol/l)
• Uncontrolled hypertension
• Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
• Presence of NYHA Class III or IV chronic heart failure
• MI or angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to do Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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Locations

United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, AL36207
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
United States, Texas
Icon Clinical Research
San Antonio, Texas, United States, 78230
Denmark
Novartis Investigator Site
Copenhagen, Denmark
Germany
Novartis Investigator Site
Mainz, Germany
Novartis Investigator Site
Mannheim, Germany
Novartis Investigator Site
Neuss, Germany
Israel
Novartis Investigator Site
Rehovot, Israel
Novartis Investigator Site
Tel Aviv, Israel
Novartis Investigator Site
Zrifin, Israel
Netherlands
Novartis Investigator Site
Amsterdam, Netherlands

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00907998 History of Changes
Other Study ID Numbers:	CAPL180A2210B; EudraCT 2009-010877-19
First Posted:	May 25, 2009
Last Update Posted:	November 20, 2009
Last Verified:	November 2009

Keywords provided by Novartis:

Coronary heart disease; APL180

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia	Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases