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A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part-1 ASP group | Experimental | ASP0456 receiving group |
|
| Part-1 Placebo group | Placebo Comparator | Placebo treatment |
|
| Part-2 group | Experimental | cross-over study group to evaluate food effect on ASP0456 plasma concentration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP0456 | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change | For 48 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests | For 48 hours after dosing |
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Inclusion Criteria:
Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
Body weight (at screening);
BMI(at screening): ≥17.6,<26.4
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Cental Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantou | Japan |
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| ID | Term |
|---|---|
| C523483 | linaclotide |
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| Placebo | Drug | oral |
|