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| Name | Class |
|---|---|
| South Australian Health and Medical Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | RVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 40 mg |
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| Group B | Experimental | RVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 20 mg |
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| Group C | Experimental | RVX000222 200 mg (100 mg b.i.d.) + Atorvastatin 80 mg |
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| Group D | Experimental | RVX000222 200 mg (100 mg b.i.d.) + Rosuvastatin 40 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RVX000222 | Drug | capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Sepehr Shakib | Royal Adelaide Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital / CMAX | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
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| ID | Term |
|---|---|
| C000628794 | apabetalone |
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Rosuvastatin | Drug | 20 mg daily, 28-42 days |
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| Atorvastatin | Drug | 40 mg daily, 28-42 days |
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| Rosuvastatin | Drug | 40 mg daily, 28-42 days |
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| Atorvastatin | Drug | 80 mg daily, 28-42 days |
|
| 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. | 14 |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |