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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of repeated doses of a new investigational drug (ACU-4429) in healthy human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACU-4429 tablet | Experimental |
| |
| matching placebo tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACU-4429 | Drug | administered orally once a day for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics as measured by plasma ACU-4429 drug levels | 16 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Lewis, MD | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000592692 | emixustat |
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| matching placebo tablet |
| Drug |
administered orally once a day for 14 days |
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