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

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 - MDCO-216 in healthy volunteers & patients with proven stable CAD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39847

Enrollment

Registered

2012-11-29

Start date

2013-02-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis coronary artery disease

Interventions

IV administration of single ascending dose of MDCO-216 or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Safety, tolerability and pharmacokinetics of escalating single doses of MDCO-216	—

Secondary

Measure	Time frame
Pharmacodynamics effects of a single dose of MDCO-216 on plasma lipid profiles including free cholesterol and exploratory measures of cholesterol efflux.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)