NCT00768274

Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol

A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of 28-Day Oral Dosing of RVX000222 in Healthy Subjects and Subjects With Low High Density Lipoprotein (HDL)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Resverlogix Corp · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.

Detailed description

One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease which still remains a leading cause of death around the world. The major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL). HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the capacity to reverse coronary atherosclerosis. RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of ApoA-I and HDL.

Conditions

• Dyslipidemia
• Atherosclerosis
• Acute Coronary Syndrome
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	RVX000222	RVX000222 twice daily (b.i.d.) for 28 days
DRUG	Placebo	Placebo twice daily (b.i.d.) for 28 days

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-10-08
• Last updated: 2022-11-04

Locations

1 site across 1 country: United States