Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kyntra Bio | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP1517 fasting then fed | Experimental | Subjects will receive a single oral dose of ASP1517 under fasting conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fed conditions in period 2. |
|
| ASP1517 fed then fasting | Experimental | Subjects will receive a single oral dose of ASP1517 under fed conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fasting conditions in period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1517 | Drug | Oral |
|
| 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 Day 4 of each treatment period |
| PK parameter of ASP1517 in Plasma: Cmax | Cmax: Maximum concentration | Up to Day 4 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of ASP1517 in Plasma: AUClast | AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration | Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Plasma: CL/F |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00001 | Tokyo | Tokyo | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CL/F: Apparent total systemic clearance
| Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Plasma: λz | λz: Terminal rate constant | Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Plasma: MRTinf | MRTinf: Mean residence time extrapolated to infinity | Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Plasma: t1/2 | t1/2: Terminal elimination half-life | Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Plasma: tmax | tmax: Time of Cmax | Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Plasma: tlag | tlag: Lag time | Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Plasma: Vz/F | Vz/F: Apparent volume of distribution during the terminal elimination phase | Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Urine: Ae | Ae: Cumulative amount of ASP1517 excreted into urine | Up to Day 4 of each treatment period |
| PK parameter of ASP1517 in Urine: CLR | CLR: Renal clearance | Up to Day 4 of each treatment period |
| Safety assessed by adverse events | Up to Day 9 of Period 2 |
| Number of participants with abnormal vital signs and/or adverse events during treatment period | Up to Day 9 of Period 2 |
| Number of participants with abnormal laboratory values and/or adverse events during treatment period | Up to Day 9 of Period 2 |
| Number of participants with abnormal standard 12-Lead ECG and/or adverse events during treatment period | ECG: Electrocardiogram | Up to Day 9 of Period 2 |