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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000857-29 |
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The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP311 capsules | Experimental | Patients will receive TAP311 capsule orally once daily for 14 days. |
|
| Placebo of TAP311 capsules | Placebo Comparator | Matching placebo to TAP311 capsule, once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP311 capsules | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported. | 14 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss) | Day 1 - Cmax, Day 14 - Cmaxss, from the plasma concentration-time data. Each parameters will be one outcome measure | Day 1 and Day 14 |
| Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss) |
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Inclusion Criteria:
Exclusion Criteria:
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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 | ||
| Novartis Investigative Site |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The time to reach the maximum concentration after drug administration at steady state(Tmax, ss) |
| Day 1 and Day 14 profile |
| Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | Day 1 |
| Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data | The Racc ratio from the plasma concentration-time data | Day 14 |
| Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data | The AUCtau, from the plasma concentration-time data | Day 14 |
| Amman |
| 11941 |
| Jordan |
| Novartis Investigative Site | Taichung | Taiwan | 40447 | Taiwan |