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The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-8995 1 mg | Experimental |
| |
| TA-8995 2.5 mg | Experimental |
| |
| TA-8995 5 mg | Experimental |
| |
| TA-8995 10 mg | Experimental |
| |
| TA-8995 25 mg | Experimental |
| |
| Placebo (TA-8995 1mg) | Placebo Comparator |
| |
| Placebo (TA-8995 2.5mg) | Placebo Comparator |
| |
| Placebo (TA-8995 5mg) | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-8995 | Drug | Drug: TA-8995 1mg |
| |
| TA-8995 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 336 hours post dose | |
| Laboratory tests (haematology, biochemistry and urinalysis) | 336 hours post dose | |
| Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature) | 336 hours post dose | |
| Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-Ï„, Steady-state) | 7 days post the final dose | |
| The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state) | 7 days post the final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol ester transfer protein (CETP) activity (%) | 7 days post the final dose | |
| CETP concentration (mg/mL) | 4 hours after the first and the fibal dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Weber, MD | Momentum Pharma Services GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momentum Pharma Services GmbH | Hamburg | 22769 | Germany |
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| Placebo (TA-8995 10mg) | Placebo Comparator |
|
| Placebo (TA-8995 25mg) | Placebo Comparator |
|
| Drug |
Drug: TA-8995 2.5mg |
|
| TA-8995 | Drug | Drug: TA-8995 5mg |
|
| TA-8995 | Drug | Drug: TA-8995 10mg |
|
| TA-8995 | Drug | Drug: TA-8995 25mg |
|
| Placebo | Drug | Placebo (TA-8995 1mg) |
|
| Placebo | Drug | Placebo (TA-8995 2.5mg) |
|
| Placebo | Drug | Placebo (TA-8995 5mg) |
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| Placebo | Drug | Placebo (TA-8995 10mg) |
|
| Placebo | Drug | Placebo (TA-8995 25mg) |
|
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000597751 | TA-8995 |
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