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This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP311 in Healthy Volunteers | Experimental |
| |
| Matching Placebo | Placebo Comparator | Healthy Volunteers and Patients will be treated in Placebo group. |
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| TAP311 and Simvastatin | Experimental |
| |
| TAP311 in Patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP311 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia | Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis). | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia. | 25 timepoints over 17 days | |
| Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Miramar | Florida | 33025 | United States |
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| Label | URL |
|---|---|
| Results for CTAP311X2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Simvastatin (and metabolite) blood concentration before and after TAP311 treatment.
| 10 days |
| Effect of food on TAP311 blood concentration in healthy subjects. | TAP311 blood concentration when the drug is administered with and without food. | 3 days |
| Effects of TAP311 on total cholesterol in patients with dyslipidemia | Total cholesterol blood concentration before and after TAP311 treatment. | 8 timepoints over 15 days |
| Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia | LDL-C blood concentration before and after TAP311 treatment. | 8 timepoints over 15 days |
| Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia. | HDL-C blood concentration before and after TAP311 treatment. | 8 timepoints over 15 days |
| Effects of TAP311 on triglycerides in patients with Dyslipidemia | Triglycerides concentration in blood before and after TAP311 treatment. | 8 timepoints over 15 days |