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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00568594 |
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 |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo 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 |
Estimated Enrollment: | 120 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: APL180 |
2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria for both healthy volunteers and patients:
Other protocol-defined inclusion/exclusion criteria may apply
Contact: NOVARTIS | +41 61 324 1111 |
United States, Pennsylvania | |
Novartis Investigator Site | Recruiting |
Philadelphia, Pennsylvania, United States | |
Contact: Novartis 862-778-8300 | |
Belgium | |
Novartis Investigator Site | Completed |
Antwerp, Belgium | |
Novartis Investigator Site | Withdrawn |
Leuven, Belgium | |
Denmark | |
Novartis Investigator Site | Recruiting |
Birkeroed, 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 | Completed |
Groningen, Netherlands | |
South Africa | |
Novartis Investigator Site | Recruiting |
Bloemfontein, South Africa | |
Contact: Novartis +41 61 324 1111 | |
United Kingdom | |
Novartis Investigator Site | Completed |
Harrow, United Kingdom |
Principal Investigator: | NOVARTIS | Novartis investigative site |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CAPL180A2201 |
Study First Received: | December 5, 2007 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00568594 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United States: Food and Drug Administration; Israel: Ministry of Health; South Africa: Medicines Control Council; Belgium: Federaal Agenschap voor Geneesmiddelen en Gezondheidsproducten; Denmark: Danish Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
apolipoprotein A-I, atherosclerosis, HDL, inflammation, peptide mimetics |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Healthy Arteriosclerosis Ischemia Coronary Artery Disease Inflammation |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |