DyslipidemiaPhase 1/2NCT00673881
ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study
A Phase 1/2 study testing choline fenofibrate in people with Dyslipidemia, run by Radiant Research at 1 site in United States.
Trial 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]… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- choline fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiant Research, 515 N State St, #2700
Chicago, Illinois, 60610
About this study
Official title: ABT-335 (Choline Fenofibrate)Reverse Cholesterol Transport (RCT) Study
The objectives of the study are:
- 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).
- To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.
- To obtain pilot data for power calculations for subsequent comparative study.
Read the 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
- Being tested
- choline fenofibrate
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choline fenofibrateDrug
Also called ABT-335
135 mg choline fenofibrate daily(oral, capsule)
| Study group | Role | What they receive |
|---|---|---|
| Abt-335 | Experimental | ABT-335 (choline fenofibrate) Receives: Drug: choline fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Baseline to 12 weeks
Total Cholesterol
Mean Change in total cholesterol from baseline to End-of-treatment (Day 95)
Measured: 12 weeks
Secondary outcomes (7)
Plasma Cholesterol Efflux
Change in efflux rate from baseline to end-of-treatment. The efflux rate of cholesterol from peripheral tissues into the plasma was measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® or Liposyn® and 10 % ethanol was given piggy-backed into normal saline over 24 hours. This was used to determine rate of appearance (Ra) cholesterol, measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol traced into biliary sterols.
Measured: 12 weeks
Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)
Change in FCR from baseline to end-of-treatment (12 weeks)
Measured: Baseline to 12 weeks
Percent Change in de Novo Cholesterol Synthesis
Plasma DNC was measured three times from blood draws on the 3 visits in the 10 day period following the isotope infusion at baseline and again at end-of-treatment at 12 weeks, and expressed in percent. Change from baseline to end-of-treatment expressed as percent.
Measured: Baseline to 12 weeks
Change in Neutral Sterol Excretion
The excretion rate of fecal neutral and acidic sterols was measured as mg/day, for each individual three times during the 10 day period following the isotope infusions at baseline and end-of-treatment.
Measured: baseline to 12 weeks
Change in Bile Acid Excretion
Change in bile acid excretion from baseline to end-of-treatment
Measured: Baseline to 12 weeks
Neutral Sterol Endogenous Excretion
Change in neutral sterol endogenous excretion from baseline to end-of-treatment
Measured: 12 weeks
Endogenous Bile Acid Excretion
Change in endogenous bile acid excretion from baseline to end-of-treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiant Research
- Sponsor type
- University, hospital or other
- Investigators
- Michael H Davidson, MD,FACC, Principal investigator, Radiant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673881
- Sponsor's protocol ID
- ABT-335-001
- Status last verified
- Mar 2011
- First submitted
- 5 May 2008
- Last updated
- 20 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABT-335 (Choline Fenofibrate)Reverse Cholesterol Transport (RCT) Study
- ClinicalTrials.gov ID
- NCT00673881
- Acronym / sponsor ID
- ABT-335-001
- Conditions
- Dyslipidemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Radiant ResearchUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 20 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are:
- 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).
- To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abt-335 | Experimental | Drug: choline fenofibrateABT-335 (choline fenofibrate) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| choline fenofibrateAlso: ABT-335135 mg choline fenofibrate daily(oral, capsule) | Drug | Abt-335 |
Primary outcome
Mean Change in Calculated Low Density Lipoprotein Cholesterol
Time frame: baseline to 12 weeks
Mean change in calculated LDL, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,average Day 95)
Mean Change in Plasma Triglycerides
Time frame: baseline to 12 weeks
Change in plasma triglyceride, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)
Mean Change in High Density Lipoprotein Cholesterol
Time frame: Baseline to 12 weeks
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)
Total Cholesterol
Time frame: 12 weeks
Mean Change in total cholesterol from baseline to End-of-treatment (Day 95)
7 secondary outcomes
Plasma Cholesterol Efflux
Time frame: 12 weeks
Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)
Time frame: Baseline to 12 weeks
Percent Change in de Novo Cholesterol Synthesis
Time frame: Baseline to 12 weeks
Change in Neutral Sterol Excretion
Time frame: baseline to 12 weeks
Change in Bile Acid Excretion
Time frame: Baseline to 12 weeks
Neutral Sterol Endogenous Excretion
Time frame: 12 weeks
Endogenous Bile Acid Excretion
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Davidson, MD,FACC principal investigator
Radiant Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing choline fenofibrate in people with Dyslipidemia, run by Radiant Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Calculated Low Density Lipoprotein Cholesterol (time frame: baseline to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2011; AzTrials last refreshed its copy on 2 Nov 2026.