DyslipidemiaPhase 1/2NCT00768274
Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol
A Phase 1/2 study testing RVX000222 in people with Dyslipidemia and Atherosclerosis, run by Resverlogix Corp at 1 site in United States.
Trial summary
The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Atherosclerosis, Acute Coronary Syndrome
- What is being tested?
- RVX000222
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who meet the following criteria may be enrolled:
- Be men or women between 18 and 65 years old, inclusive
- Weigh between 60 kg and 110 kg, inclusive, and have a BMI ≥25 kg/m2.
- Healthy volunteers with normal or low HDL
- If female, non-pregnant (as determined by a negative serum pregnancy test at Screening), non-lactating, and not of childbearing-potential or willing to practice an acceptable form of birth control. If male, be willing to practice an acceptable form of birth control.
Who cannot join
- Subjects who meet any of the following criteria will not be enrolled:
- Have presently, or have a history of, clinically significant disease, including cardiovascular, gastrointestinal, renal, hepatic, pulmonary, endocrine, hematologic, vascular, immunologic, metabolic, neurological, or collagen disease, as judged by the Investigator.
- Have active cholecystitis or gallbladder symptoms within 60 days prior to Check-in (subjects who have had a cholecystectomy are not excluded from this study).
- Have had a clinically significant illness, in the opinion of the Investigator, within 30 days prior to Check-in.
- Have hypertension that is currently being treated, or uncontrolled hypertension
- Have a serum creatinine >1.5 mg/dL, hemoglobin <11.2 g/dL, or white blood cell count <4000/μL.
- Have positive test results for HIV, hepatitis A, B, or C.
- Have a positive result on drug screen testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Dallas, Texas, 75247
About this study
Official title: A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of 28-Day Oral Dosing of RVX000222 in Healthy Subjects and Subjects With Low High Density Lipoprotein (HDL)
The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.
Read the detailed description
One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease which still remains a leading cause of death around the world. The major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL).
HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the capacity to reverse coronary atherosclerosis.
RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of ApoA-I and HDL.
- Being tested
- RVX000222, Placebo
- Keywords
- Cholesterol, High density lipoprotein, Dyslipidemia, Atherosclerosis, Apolipoprotein A-I
- Medical subject headings
- Dyslipidemias, Atherosclerosis, Acute Coronary Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVX000222Drug
Also called RVX-208, apabetalone
RVX000222 twice daily (b.i.d.) for 28 days
PlaceboDrug
Placebo twice daily (b.i.d.) for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Low-dose apabetalone (RVX000222) or placebo Receives: Drug: RVX000222; Drug: Placebo |
| Arm B | Experimental | apabetalone (RVX000222) Dose-escalation or placebo Receives: Drug: RVX000222; Drug: Placebo |
| Arm C | Experimental | high-dose apabetalone (RVX000222) or placebo Receives: Drug: RVX000222; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo.
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resverlogix Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan Gordon, MD, PhD, Study director, Resverlogix Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768274
- Sponsor's protocol ID
- RVX222-CS-003
- Status last verified
- Jul 2016
- First submitted
- 7 Oct 2008
- Last updated
- 4 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of 28-Day Oral Dosing of RVX000222 in Healthy Subjects and Subjects With Low High Density Lipoprotein (HDL)
- ClinicalTrials.gov ID
- NCT00768274
- Acronym / sponsor ID
- RVX222-CS-003
- Keywords
- Cholesterol, High density lipoprotein, Dyslipidemia, Atherosclerosis, Apolipoprotein A-I
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Resverlogix CorpIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.
Detailed description
One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease which still remains a leading cause of death around the world. The major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL).
HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the capacity to reverse coronary atherosclerosis.
RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of ApoA-I and HDL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: RVX000222, Drug: PlaceboLow-dose apabetalone (RVX000222) or placebo |
| Arm B | Experimental | Drug: RVX000222, Drug: Placeboapabetalone (RVX000222) Dose-escalation or placebo |
| Arm C | Experimental | Drug: RVX000222, Drug: Placebohigh-dose apabetalone (RVX000222) or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who meet the following criteria may be enrolled:
Key exclusion criteria (8 listed)
- Subjects who meet any of the following criteria will not be enrolled:
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 |
|---|---|---|
| RVX000222Also: RVX-208, apabetaloneRVX000222 twice daily (b.i.d.) for 28 days | Drug | Arm A, Arm B, Arm C |
| PlaceboPlacebo twice daily (b.i.d.) for 28 days | Drug | Arm A, Arm B, Arm C |
Primary outcome
Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo.
Time frame: 1-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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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.
Allan Gordon, MD, PhD study director
Resverlogix Corp
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 RVX000222 in people with Dyslipidemia and Atherosclerosis, run by Resverlogix Corp 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 5 inclusion and 8 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 4 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo. (time frame: 1-month). 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 4 Nov 2022.