A single ascending dose, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MDCO-216 infusion in healthy volunteers and in patients with known stable coronary artery disease
- Conditions
- atherosclerosiscoronary artery disease1001108210003216
- Registration Number
- NL-OMON39847
- Lead Sponsor
- Medicines Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Healthy volunteers:
Males or females, 18-55 years of age, without clinically significant abnormalities who are willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures;Patients
Male or female patients 45 - 80 years of age with proven stable atherosclerotic coronary artery disease who are willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures
Healthy volunteers:
Use of medication or over-the-counter substances; any surgical or medical condition which, in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug.;Patients:
Myocardial infarct within the last 6 months; Any percutaneous revascularization within the last 6 months; Cerebral ischemic event defined as stroke or transient ischemic attack within the last 1 year; any surgical or medical condition which, in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety, tolerability and pharmacokinetics of escalating single doses of<br /><br>MDCO-216</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacodynamics effects of a single dose of MDCO-216 on plasma lipid profiles<br /><br>including free cholesterol and exploratory measures of cholesterol efflux.</p><br>