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The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose in Caucasian men | Experimental |
| |
| Age-effect in Caucasian men | Experimental |
| |
| Gender-effect in Caucasian women | Experimental |
| |
| Single ascending dose in Japanese men | Experimental |
| |
| Placebo: Single ascending dose in Caucasian men | Placebo Comparator |
| |
| Placebo: Age-effect in Caucasian men | Placebo Comparator |
| |
| Placeo: Gender-effect in Caucasian women | Placebo Comparator |
| |
| Placebo: Single ascending dose in Japanese men |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-8995 | Drug | TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg |
|
| 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 | |
| Peak concentration (ng/mL) of TA-8995 | 336 hours post dose | |
| Time of peak concentration (hr) of TA-8995 | 336 hours post dose | |
| Area under the concentration-time curve (mg/L・hr) up to 24 h (AUC0-24), 72 h (AUC0-72), 168 h (AUC0-168), 336 h (AUC0-336) and infinity (AUC0-∞) of TA-8995 | 336 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL) | 336 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Warrington, MA MD FRCP FFPM | Hammersmith Medicines Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research (HMR) | London | NW10 7EW | United Kingdom |
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| Placebo Comparator |
|
| TA-8995 | Drug | Drug: TA-8995 25 mg |
|
| TA-8995 | Drug | Drug: TA-8995 25 mg |
|
| TA-8995 | Drug | Drug: TA-8995 25, 50, 100 and 150 mg |
|
| Placebo | Drug | Single ascending dose in Caucasian men |
|
| Placebo | Drug | Age-effect in Caucasian men |
|
| Placebo | Drug | Gender-effect in Caucasian women |
|
| Placebo | Drug | Single ascending dose in Japanese men |
|
| 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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