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The purpose of this study is to investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | Japanese and Non-Japanese subjects receiving K-312 50 mg QD |
|
| Cohort 2 | Other | Japanese and Non-Japanese subjects receiving K-312 100 mg QD |
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| Cohort 3 | Other | Japanese and Non-Japanese subjects receiving K-312 200 mg QD |
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| Cohort 4 | Other | Japanese and Non-Japanese subjects receiving K-312 400 mg QD |
|
| Cohort 5 | Other | Japanese and Non-Japanese subjects receiving K-312 25 mg QD |
|
| Cohort 6 | Other | Japanese and Non-Japanese subjects receiving K-312 10 mg QD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-312 10 mg QD | Drug |
| ||
| K-312 25 mg QD |
| Measure | Description | Time Frame |
|---|---|---|
| CETP activity | Days 1, 3, 6, 11, 16, 21, 27 and 30 | |
| Area under the plasma concentration | Days 1 and 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | United States |
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|
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| K-312 50 mg QD | Drug |
|
| K-312 100 mg QD | Drug |
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| K-312 200 mg QD | Drug |
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| K-312 400 mg QD | Drug |
|
| Placebo | Other |
|
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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