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Characterization of Multi-dose RVX000222 in Combination With Statin Treatment in Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01863225
Recruitment Status : Terminated
First Posted : May 27, 2013
Last Update Posted : May 12, 2015
Sponsor:
Collaborator:
South Australian Health and Medical Research Institute
Information provided by (Responsible Party):
Resverlogix Corp

Brief 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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Coronary Artery Disease Drug: RVX000222 Drug: Rosuvastatin Drug: Atorvastatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : May 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
RVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 40 mg
Drug: RVX000222
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days
Other Name: RVX-208

Drug: Atorvastatin
40 mg daily, 28-42 days

Experimental: Group B
RVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 20 mg
Drug: RVX000222
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days
Other Name: RVX-208

Drug: Rosuvastatin
20 mg daily, 28-42 days

Experimental: Group C
RVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 80 mg
Drug: RVX000222
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days
Other Name: RVX-208

Drug: Atorvastatin
80 mg daily, 28-42 days

Experimental: Group D
RVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 40 mg
Drug: RVX000222
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days
Other Name: RVX-208

Drug: Rosuvastatin
40 mg daily, 28-42 days




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    Adverse events, serious adverse events, vital signs, clinical chemistry and haematological variables will be collected and summarized across treatment groups.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863225


Locations
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Australia, South Australia
Royal Adelaide Hospital / CMAX
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Resverlogix Corp
South Australian Health and Medical Research Institute
Investigators
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Principal Investigator: Dr. Sepehr Shakib Royal Adelaide Hospital
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Responsible Party: Resverlogix Corp
ClinicalTrials.gov Identifier: NCT01863225    
Other Study ID Numbers: RVX222-CS-009
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Coronary Artery Disease
Dyslipidemias
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors