Primary objective: To investigate the safety, tolerability and pharmacokinetics of escalating single doses of MDCO-216 in healthy volunteers and in patients with known stable coronary artery disease.Secondary objective: To characterize the…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety, tolerability and pharmacokinetics of escalating single doses of
MDCO-216
Secondary outcome
Pharmacodynamics effects of a single dose of MDCO-216 on plasma lipid profiles
including free cholesterol and exploratory measures of cholesterol efflux.
Background summary
MDCO-216 is being developed as a disease-modifying treatment for patients with
atherosclerotic disease and acute coronary syndrome (ACS) to limit disease
progression by reducing cholesterol deposition in arterial walls and reduce the
occurrence of atherothrombotic events. MDCO-216 mimics high density
lipoprotein cholesterol (HDL) in structure and function and has been shown to
promote the removal of cholesterol from atherosclerotic plaques in animal
studies. Earlier clinical studies with a comparable compound demonstrated
that HDL-mimetica have the capability to decrease plaque volume in coronary
artery atherosclerotic plaques.
Study objective
Primary objective: To investigate the safety, tolerability and pharmacokinetics
of escalating single doses of MDCO-216 in healthy volunteers and in patients
with known stable coronary artery disease.
Secondary objective: To characterize the pharmacodynamics effects of a single
dose of MDCO-216 in healthy volunteers and in patients with known stable
coronary artery disease as measured by effects on plasma lipid profiles
including free cholesterol and exploratory measures of cholesterol efflux.
Study design
I: Five (5) parallel cohorts of healthy volunteers who will be given single
ascending doses of MDCO-216 or placebo (active:placebo 3:1)
II: Four (4) parallel cohorts of patients with proven, stable CAD who will be
given single ascending doses of MDCO-216 or placebo (act=4: plac:2)
Intervention
IV administration of single ascending dose of MDCO-216 or placebo
Study burden and risks
Burden: medical screening ; 2 days admitted to clin research unit for dosing,
measurements en sampling; follow-up visits
Risk: unknown adverse events that were not identified in pre-clinical
experiments
Sylvan Way 8
Parsippany NJ 07054
US
Sylvan Way 8
Parsippany NJ 07054
US
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004370-26-NL |
| CCMO | NL42519.056.12 |