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| Name | Class |
|---|---|
| Kyntra Bio | INDUSTRY |
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The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Treatment arm includes 4 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® without a time lag, single dose of ASP1517 + Kremezin® with a time lag (1 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (1 h after ASP1517 administration) |
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| Group 2 | Experimental | Treatment arm includes 3 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® with a time lag (2 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (2 h after ASP1517 administration) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1517 | Drug | Oral |
| |
| Kremezin® |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter of ASP1517: AUCinf | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing |
| PK parameter of ASP1517: Cmax | Cmax: Maximum concentration | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of ASP1517: AUClast | AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing |
| PK parameters of ASP1517: CL/F |
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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 | Tokyo | Tokyo | Japan |
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| ID | Term |
|---|---|
| C040896 | AST 120 |
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| Drug |
Oral |
|
CL/F: Apparent total systemic clearance |
| Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing |
| PK parameters of ASP1517: t1/2 | t1/2: Terminal elimination half-life | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing |
| PK parameters of ASP1517: tmax | tmax: Time of Cmax | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing |
| PK parameters of ASP1517: tlag | tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing |
| PK parameters of ASP1517: Vz/F | Vz/F: Apparent volume of distribution during the terminal elimination phase | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing |
| Safety assessed by Adverse events | Up to 72 hours after final study drug dosing |
| Safety assessed by Vital signs | Supine blood pressure, supine pulse rate and axillary body temperature | Up to 72 hours after each study drug dosing |
| Safety assessed by Laboratory tests | Hematology, blood biochemistry and urinalysis | Up to 72 hours after each study drug dosing |
| Safety assessed by Standard 12-lead ECG | ECG: Electrocardiogram | Up to 72 hours after each study drug dosing |