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The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP2151 Low dose in non-elderly subjects group | Experimental | Subjects will receive ASP2151 daily on Days 1 to 7. |
|
| ASP2151 High dose in non-elderly subjects group | Experimental | Subjects will receive ASP2151 daily on Days 1 to 7. |
|
| ASP2151 Low dose in elderly subjects group | Experimental | Subjects will receive ASP2151 daily on Days 1 to 7. |
|
| ASP2151 High dose in elderly subjects group | Experimental | Subjects will receive ASP2151 daily on Days 1 to 7. |
|
| Placebo in non-elderly subjects group | Placebo Comparator | Subjects will receive matching placebo daily on Days 1 to 7. |
|
| Placebo in elderly subjects group | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP2151 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ASP2151 in plasma: Cmax | Cmax: Maximum concentration | Up to Day 9 |
| Pharmacokinetics of ASP2151 in plasma: tmax | tmax: The time after dosing when Cmax occurs | Up to Day 9 |
| Pharmacokinetics of ASP2151 in plasma: t1/2 | t1/2: Apparent terminal elimination half-life | Up to Day 9 |
| Pharmacokinetics of ASP2151 in plasma: C24 | C24: Concentration at 24hours after dosing | Up to Day 9 |
| Pharmacokinetics of ASP2151 in plasma: AUC24 | AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing | Up to Day 9 |
| Pharmacokinetics of ASP2151 in plasma: AUCinf | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Up to Day 9 |
| Pharmacokinetics of ASP2151 in plasma: CL/F | CL/F: Apparent total systemic clearance | Up to Day 9 |
| Pharmacokinetics of ASP2151 in urine: Ae | Ae: Amount excreted in urine |
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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 |
|---|---|---|---|---|---|---|
| Site JP00001 | Osaka | Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29134426 | Derived | Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13. |
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| ID | Term |
|---|---|
| C568714 | ASP2151 |
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Subjects will receive matching placebo daily on Days 1 to 7.
|
| Placebo | Drug | Oral |
|
| Up to Day 9 |
| Pharmacokinetics of ASP2151 in urine: Cumulative Ae | Up to Day 9 |
| Pharmacokinetics of ASP2151 in urine: Ae% | Ae%: Percent of ASP2151 amount excreted in urine | Up to Day 9 |
| Pharmacokinetics of ASP2151 in urine: Cumulative Ae% | Up to Day 9 |
| Pharmacokinetics of ASP2151 in urine: CLR | CLR: Renal clearance | Up to Day 9 |
| Safety assessed by laboratory test: Hematology | Up to Day 14 |
| Safety assessed by laboratory test: blood biochemistry | Up to Day 14 |
| Safety assessed by laboratory test: urinalysis | Up to Day 14 |
| Safety assessed by Vital sign measurement: axillary body temperature | Up to Day 14 |
| Safety assessed by vital sign measurement: supine blood pressure | Up to Day 14 |
| Safety assessed by vital sign measurement: supine pulse rate | Up to Day 14 |
| Safety assessed by Standard 12-lead electrocardiogram | Up to Day 14 |
| Safety assessed by Standard 12-lead electrocardiogram for QT assessment | Up to Day 14 |
| Safety assessed by ophthalmological examination | Up to Day 14 |
| Safety assessed by incidence of adverse events | Up to Day 14 |