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

NCT00673881 | Completed Phase 1 Results

• 1 other identifier: ABT-335-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the study are:

1. 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. 2.To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.
3. 3.To obtain pilot data for power calculations for subsequent comparative study.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (4)

• Mean Change in Calculated Low Density Lipoprotein Cholesterol

  Mean change in calculated LDL, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,average Day 95)

  baseline to 12 weeks

• Mean Change in Plasma Triglycerides

  Change in plasma triglyceride, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)

  baseline to 12 weeks

• Mean Change in High Density Lipoprotein Cholesterol

  Mean change in plasma high density plasma lipoprotein cholesterol (HDL-C)baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)

  Baseline to 12 weeks

• Total Cholesterol

  Mean Change in total cholesterol from baseline to End-of-treatment (Day 95)

  12 weeks

Secondary Outcomes (7)

• Plasma Cholesterol Efflux

  12 weeks

• Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)

  Baseline to 12 weeks

• Percent Change in de Novo Cholesterol Synthesis

  Baseline to 12 weeks

• Change in Neutral Sterol Excretion

  baseline to 12 weeks

• Change in Bile Acid Excretion

  Baseline to 12 weeks

Study Arms (1)

Abt-335

EXPERIMENTAL

ABT-335 (choline fenofibrate)

Drug: choline fenofibrate

Interventions

choline fenofibrate DRUG

135 mg choline fenofibrate daily(oral, capsule)

Also known as: ABT-335

Abt-335

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radiant Research: lead

Study Sites (1)

Radiant Research, 515 N State St, #2700

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Michael H. Davidson, MD FACC
• Organization: Radiant Research

michaeldavidson@radiantresearch.com

312-494-2220

Study Officials

• Michael H Davidson, MD,FACC

  Radiant Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 20, 2011
• Results First Posted: April 20, 2011

Record last verified: 2011-03

Locations

US (1)