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This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.
In each step (lowest dose, middle dose, highest dose), subjects are randomly assigned in a double blinded manner to receive either ASP7991 (n=9) or Placebo (n=3) and are administered repeatedly. Once daily, the subjects are administered ASP7991 or placebo orally 30 minutes after breakfast with 150 mL water for 7 days. After the each step the sponsor evaluates the safety in the blinded manner for deciding an escalation to the step.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose ASP7991 | Experimental |
| |
| middle dose ASP7991 | Experimental |
| |
| high dose ASP7991 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP7991 | Drug | oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and slit lamp examination | For 96 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations unchanged drug; AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F | For 96 hours after dosing | |
| Urinary concentrations unchanged drug; Aelast, Aelast%, CLR | For 96 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| ID | Term |
|---|---|
| C000628269 | ASP7991 |
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| Placebo |
| Drug |
oral |
|