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| Name | Class |
|---|---|
| Kyntra Bio | INDUSTRY |
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The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP1517 alone period preceding group | Experimental | Subjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2. |
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| ASP1517+lanthanum period preceding group | Experimental | Subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone in period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1517 | Drug | Oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter of ASP1517 in plasma: AUCINF | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: AUC24h | AUC24h: Area under the concentration-time curve from the time of dosing to 24h | Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: Cmax | Cmax: Maximum concentration | Up to 72hr after each dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of ASP1517 in plasma: AUClast | AUC last: Area under the concentration-time curve from the time of dosing to the last measurable concentration | Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: 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 |
|---|---|
| C119467 | lanthanum carbonate |
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| Lanthanum carbonate hydrate | Drug | Oral dose |
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CL/F: Apparent total systemic clearance
| Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: t1/2 | t1/2: Terminal elimination half-life | Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: Lambda z | Lambda z: Terminal elimination rate constant | Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: MRTinf | MRTinf: Mean residence time from the time of dosing extrapolated to time infinity | Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: tmax | tmax : Time of Cmax | Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: tlag | tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration | Up to 72hr after each dosing |
| PK parameter of ASP1517 in plasma: Vz/F | Vz/F: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing | Up to 72hr after each dosing |
| Safety assessed by incidence of adverse events | Up to 7 days after drug dosing of period 2 |
| Safety assessed by supine blood pressure | Up to 7 days after drug dosing of period 2 |
| Safety assessed by supine pulse rate | Up to 7 days after drug dosing of period 2 |
| Safety assessed by axillary body temperature | Up to 7 days after drug dosing of period 2 |
| Safety assessed by Laboratory tests: Hematology | Up to 7 days after drug dosing of period 2 |
| Safety assessed by Laboratory tests: Blood biochemistry | Up to 7 days after drug dosing of period 2 |
| Safety assessed by Laboratory tests: Urinalysis | Up to 7 days after drug dosing of period 2 |
| Safety assessed by 12-lead electrocardiogram | Up to 7 days after drug dosing of period 2 |