NCT00673881

ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study

ABT-335 (Choline Fenofibrate)Reverse Cholesterol Transport (RCT) Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Radiant Research · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The objectives of the study are: 1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT (reverse cholesterol transport) in men and post-menopausal women diagnosed with dyslipidemia (i.e., low high-density lipoprotein \[HDL\] cholesterol levels and elevated triglyceride \[TG\] concentrations). 2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL. 3. To obtain pilot data for power calculations for subsequent comparative study.

Detailed description

This trial assesses the effects of ABT-335 on RCT as measured by cholesterol efflux or rate of appearance of cholesterol (Ra in mg/kg/hr), cholesterol excretion (%/day), RCT efflux (mg/kg/day) and de novo cholesterol synthesis (%) during a baseline period (7 days) and during a treatment period (94 days). The goal of using RCT to reverse atherosclerosis is to increase the rate of cholesterol export or "efflux" from the tissues and plaques. An increase in this cholesterol efflux rate should shrink arterial plaques by decreasing their static accumulation of cholesterol. While some currently marketed drugs have a positive impact on RCT by increasing the rate of cholesterol excretion from the body, no drug has yet been approved to increase the rate of cholesterol efflux from the tissues

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	choline fenofibrate	135 mg choline fenofibrate daily(oral, capsule)

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-05-07
• Last updated: 2011-04-20
• Results posted: 2011-04-20

Locations

1 site across 1 country: United States