DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Radiant Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemia

Intervention: choline fenofibrate (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Radiant Research

Official(s) and/or principal investigator(s):
Michael H Davidson, MD,FACC, Principal Investigator, Affiliation: Radiant Research

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Mean Change in Calculated Low Density Lipoprotein Cholesterol

Mean Change in Plasma Triglycerides

Mean Change in High Density Lipoprotein Cholesterol

Total Cholesterol

Secondary outcome:

Plasma Cholesterol Efflux

Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)

Percent Change in de Novo Cholesterol Synthesis

Change in Neutral Sterol Excretion

Change in Bile Acid Excretion

Neutral Sterol Endogenous Excretion

Endogenous Bile Acid Excretion

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

Eligibility

Minimum age: 21 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male, non-smoker, 21 - 75 years of age inclusive.

2. Female, non-smoker, 40 - 75 years of age inclusive.

3. Post-menopausal women, as defined by lack of menses for at least 2 years and age > 55, OR history of documented bilateral surgical oophorectomy, confirmed with an elevated follicle-stimulating hormone (FSH) at screening. 4. HDL concentration (≤ 50 mg/dl women, ≤ 40mg/dl men) 5. TG concentration 150-500 mg/dl, inclusive 6. Ability to give informed consent Exclusion Criteria: 1. Subject has history of diabetes mellitus, active hepatitis, gall bladder disease, gastric bypass surgery, or clinically significant abnormalities on screening (prestudy) physical examination or laboratory tests. 2. Screening laboratory tests with hematocrit <30%, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2X upper limit of normal, abnormal thyroid-stimulating hormone (TSH), fasting glucose ≥126 mg/dl. 3. Renal impairment with creatinine clearance < 80 ml/min. 4. Treatment within the last 6 months with drugs known to alter lipid metabolism including beta blockers, thiazide diuretics, bile acid resins, ezetimibe, fibrates, niacin, and fish oils (see Appendix 1). Washout of fibrates is not permitted. 5. Treatment with drugs known to interact with ABT-335, e. g., warfarin (see Appendix 1). 6. Treatment with HMG CoA reductase inhibitors (statins) within the past 4 weeks (see Appendix 1). 7. History of allergy to egg or soy products. 8. History of coronary heart disease (CHD), stroke or revascularization procedure in the six months prior to Visit 1. 9. Current or recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1. 5 oz hard liquor). 10. Participation in another clinical trial or exposure to any investigational agent within 30 days before visit 1. 11. Individual has a condition the Principal Investigator believes would interfere with his/her ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.

Locations and Contacts

Radiant Research, 515 N State St, #2700, Chicago, Illinois 60610, United States
Additional Information

Radiant has 25 wholly-owned clinical research sites (more than 8,000 clinical trials across 18 therapeutic specialties), participant recruitment services (92% enrollment rate), and a full service CRO (IND, phase 1-4, NDA/CTD)

Starting date: March 2008
Last updated: March 25, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017