Status:
COMPLETED
ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study
Lead Sponsor:
Radiant Research
Conditions:
Dyslipidemia
Eligibility:
All Genders
21-75 years
Phase:
PHASE1
PHASE2
Brief 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 wit...
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 ...
Eligibility Criteria
Inclusion
- Male, non-smoker, 21 - 75 years of age inclusive.
- Female, non-smoker, 40 - 75 years of age inclusive.
- 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.
- HDL concentration (≤ 50 mg/dl women, ≤ 40mg/dl men)
- TG concentration 150-500 mg/dl, inclusive
- Ability to give informed consent
Exclusion
- 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.
- 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.
- Renal impairment with creatinine clearance \< 80 ml/min.
- 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.
- Treatment with drugs known to interact with ABT-335, e.g., warfarin (see Appendix 1).
- Treatment with HMG CoA reductase inhibitors (statins) within the past 4 weeks (see Appendix 1).
- History of allergy to egg or soy products.
- History of coronary heart disease (CHD), stroke or revascularization procedure in the six months prior to Visit 1.
- 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).
- Participation in another clinical trial or exposure to any investigational agent within 30 days before visit 1.
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00673881
Start Date
March 1 2008
End Date
May 1 2009
Last Update
April 20 2011
Active Locations (1)
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1
Radiant Research, 515 N State St, #2700
Chicago, Illinois, United States, 60610