DyslipidemiaPhase 2NCT01863225
Characterization of Multi-dose RVX000222 in Combination With Statin Treatment in Dyslipidemia
A Phase 2 study testing RVX000222, Rosuvastatin and Atorvastatin in people with Dyslipidemia and Coronary Artery Disease, run by Resverlogix Corp at 1 site in Australia.
Trial summary
This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and atorvastatin and rosuvastatin when either statin is administered in combination with RVX000222 in subjects with dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyslipidemia, Coronary Artery Disease
- What is being tested?
- RVX000222, Rosuvastatin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteAustralia
- Study dates
- May 2013to Jun 2013
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 18 to ≤ 65 years of age with or without documented coronary artery disease.
- Taking statin therapy for at least 30 days prior to Screening (Visit 1).
- In the opinion of the investigator, patient currently on statin therapy other than atorvastatin 40 mg or rosuvastatin 20 mg or atorvastatin 80 mg or rosuvastatin 40 mg who could be switched to one of these regimens at Visit 1 for the duration of the study.
Who cannot join
- Clinically significant heart disease which will require coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement during the course of the study.
- Coronary artery bypass graft (CABG) procedure within the past 90 days.
- Have a body mass index (BMI) greater than 36 kg/m2.
- Patients of East Asian descent (due to pharmacological food effect noted for rosuvastatin).
- Previous or current diagnosis of severe heart failure (NYHA Class III-IV) or a documented left ventricular ejection fraction (LVEF) of < 25% as determined by contrast left ventriculography, radionuclide ventriculography or echocardiography. The absence of an LVEF measurement in a patient without a previous or current diagnosis of heart failure does not prohibit entry into the study.
- Patients with evidence of cardiac electrophysiologic instability including a history of uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response heart rate of > 100 beats per minute at rest within 4 weeks prior to Visit 1.
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- Evidence of renal impairment
- Have hypertension that is uncontrolled defined as 2 consecutive measurements of sitting blood pressure of systolic >160 mmHg or diastolic > 95 mmHg at Visit 1.
- Women of child-bearing potential who do not agree to use two reliable methods of birth control during the study and for one month following the last dose of study drug, or pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive ß-hCG laboratory test (≥ 5 IU/L) at the time of enrollment. Where women of child-bearing potential are defined as women not surgically sterilized and between menarche and 1 year post menopause, and a reliable method of birth control includes use of oral contraceptives or levonorgestrel; or a reliable barrier method of birth control (diaphragms; cervical caps; condoms; intrauterine devices; partner with vasectomy; or abstinence).
- Current or recent (within 12 month prior to Visit 1) treatment with immunosuppressants (e.g., Cyclosporine).
- Triglycerides > 4.5 mmol/L at screening Visit 1.
- Use of fibrates of any dose or niacin/nicotinic acid 250 mg or more within 90 days prior to Visit 1
- Any medical or surgical condition which might significantly alter the absorption, distribution, metabolism or excretion of medication including, but not limited to any of the following: cholecystitis, Crohn's disease, ulcerative colitis, or any gastric bypass alteration.
- Evidence of hepatic disease
- A total bilirubin that is > ULN by local laboratory at screening, Visit 1
- History of malignancy of any organ system, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- History or evidence of drug or alcohol abuse within 12 months of Visit 1.
- Current dependence on nicotine containing products.
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- Use of any HIV and/or chemotherapy drugs, and/or antibiotics within 30 days or 5 half-lives of Visit 2, whichever is longer.
- Use of other investigational drugs and devices at the time of enrollment, or within 30 days or 5 half-lives of Visit 2, whichever is longer.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- Any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data.
- Persons directly involved in the execution of this protocol.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Adelaide Hospital / CMAX
Adelaide, South Australia, 5000
About this study
Official title: A Phase 2 Multiple-Dose Study to Characterize the Pharmacokinetics of RVX000222 Capsule Formulation in Combination With Either Atorvastatin or Rosuvastatin in Patients With Dyslipidemia
This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and atorvastatin and rosuvastatin when either statin is administered in combination with RVX000222 in subjects with dyslipidemia.
- Conditions
- Dyslipidemia, Coronary Artery Disease
- Being tested
- RVX000222, Rosuvastatin, Atorvastatin
- Medical subject headings
- Dyslipidemias, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVX000222Drug
Also called RVX-208
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days
RosuvastatinDrug
20 mg daily, 28-42 days
AtorvastatinDrug
40 mg daily, 28-42 days
RosuvastatinDrug
40 mg daily, 28-42 days
AtorvastatinDrug
80 mg daily, 28-42 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | RVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 40 mg Receives: Drug: RVX000222; Drug: Atorvastatin |
| Group B | Experimental | RVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 20 mg Receives: Drug: RVX000222; Drug: Rosuvastatin |
| Group C | Experimental | RVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 80 mg Receives: Drug: RVX000222; Drug: Atorvastatin |
| Group D | Experimental | RVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 40 mg Receives: Drug: RVX000222; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the pharmacokinetics of RVX000222 capsule formulation in combination with either atorvastatin or rosuvastatin in patients with dyslipidemia.
The plasma concentration-time profile of RVX000222 capsule formulation and its metabolites on Days 1 and 14 of 200 mg daily RVX000222 in combination with either atorvastatin or rosuvastatin, including pharmacokinetic parameters Cmax, Tmax, Cmin, AUC0-12, AUC12-24, AUC0 24, and metabolite ratio.
Measured: 14 days
Secondary outcomes (2)
Characterization of the pharmacokinetics of atorvastatin and rosuvastatin when either is administered in combination with RVX000222 capsule formulation to patients with dyslipidemia.
The plasma concentration-time profile of either atorvastatin and metabolites or rosuvastatin and metabolites on Days -1 and 14 of 200 mg daily RVX000222 in combination with the statin, including pharmacokinetic parameters Cmax, Tmax, Cmin, AUC0-12, AUC12-24, AUC0 24, and metabolite ratio.
Measured: 14 days
Evaluation of safety and tolerability of RVX000222 capsule formulation administered in combination with stable doses of either atorvastatin or rosuvastatin in patients with dyslipidemia.
Adverse events, serious adverse events, vital signs, clinical chemistry and haematological variables will be collected and summarized across treatment groups.
Measured: 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2013
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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resverlogix Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- South Australian Health and Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Dr. Sepehr Shakib, Principal investigator, Royal Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863225
- Sponsor's protocol ID
- RVX222-CS-009
- Status last verified
- May 2015
- First submitted
- 16 May 2013
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multiple-Dose Study to Characterize the Pharmacokinetics of RVX000222 Capsule Formulation in Combination With Either Atorvastatin or Rosuvastatin in Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT01863225
- Acronym / sponsor ID
- RVX222-CS-009
- Conditions
- Dyslipidemia, Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Resverlogix CorpIndustry (pharma, biotech, devices)
- Collaborators
- South Australian Health and Medical Research Institute
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 May 2013 (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.
This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and atorvastatin and rosuvastatin when either statin is administered in combination with RVX000222 in subjects with dyslipidemia.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: RVX000222, Drug: AtorvastatinRVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 40 mg |
| Group B | Experimental | Drug: RVX000222, Drug: RosuvastatinRVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 20 mg |
| Group C | Experimental | Drug: RVX000222, Drug: AtorvastatinRVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 80 mg |
| Group D | Experimental | Drug: RVX000222, Drug: RosuvastatinRVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 40 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients ≥ 18 to ≤ 65 years of age with or without documented coronary artery disease.
- Taking statin therapy for at least 30 days prior to Screening (Visit 1).
- In the opinion of the investigator, patient currently on statin therapy other than atorvastatin 40 mg or rosuvastatin 20 mg or atorvastatin 80 mg or rosuvastatin 40 mg who could be switched to one of these regimens at Visit 1 for the duration of the study.
Key exclusion criteria (24 listed)
- Clinically significant heart disease which will require coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement during the course of the study.
- Coronary artery bypass graft (CABG) procedure within the past 90 days.
- Have a body mass index (BMI) greater than 36 kg/m2.
- Patients of East Asian descent (due to pharmacological food effect noted for rosuvastatin).
- Previous or current diagnosis of severe heart failure (NYHA Class III-IV) or a documented left ventricular ejection fraction (LVEF) of < 25% as determined by contrast left ventriculography, radionuclide ventriculography or echocardiography. The absence of an LVEF measurement in a patient without a previous or current diagnosis of heart failure does not prohibit entry into the study.
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-208capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days | Drug | Group A, Group B, Group C, Group D |
| Rosuvastatin20 mg daily, 28-42 days | Drug | Group B |
| Atorvastatin40 mg daily, 28-42 days | Drug | Group A |
| Rosuvastatin40 mg daily, 28-42 days | Drug | Group D |
| Atorvastatin80 mg daily, 28-42 days | Drug | Group C |
Primary outcome
Characterization of the pharmacokinetics of RVX000222 capsule formulation in combination with either atorvastatin or rosuvastatin in patients with dyslipidemia.
Time frame: 14 days
The plasma concentration-time profile of RVX000222 capsule formulation and its metabolites on Days 1 and 14 of 200 mg daily RVX000222 in combination with either atorvastatin or rosuvastatin, including pharmacokinetic parameters Cmax, Tmax, Cmin, AUC0-12, AUC12-24, AUC0 24, and metabolite ratio.
2 secondary outcomes
Characterization of the pharmacokinetics of atorvastatin and rosuvastatin when either is administered in combination with RVX000222 capsule formulation to patients with dyslipidemia.
Time frame: 14 days
Evaluation of safety and tolerability of RVX000222 capsule formulation administered in combination with stable doses of either atorvastatin or rosuvastatin in patients with dyslipidemia.
Time frame: 14
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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.
Dr. Sepehr Shakib principal investigator
Royal Adelaide Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVX000222, Rosuvastatin and Atorvastatin in people with Dyslipidemia and Coronary Artery Disease, run by Resverlogix Corp at 1 site in Australia.
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 3 inclusion and 24 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: stopped early, as of the sponsor's last update on 12 May 2015. 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 Australia. 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 phase mean?
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 was stopped early. Results are not available in the source record.
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?
Characterization of the pharmacokinetics of RVX000222 capsule formulation in combination with either atorvastatin or rosuvastatin in patients with dyslipidemia. (time frame: 14 days). 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 12 May 2015.