Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02952040 | A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate | PHASE1 | COMPLETED | 18 | — | — | Nov 1, 2016 | Dec 1, 2016 | Jan 25, 2017 | 1 | Japan |
| NCT02805374 | A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517 | PHASE1 | COMPLETED | 16 | — | — | Jul 1, 2016 | Aug 1, 2016 | Aug 24, 2016 | 1 | Japan |
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
AUC24h: Area under the concentration-time curve from the time of dosing to 24h
Cmax: Maximum concentration
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
|---|---|---|
| ASP1517 | DRUG | Oral dose |
| Lanthanum carbonate hydrate | DRUG | Oral dose |
Inclusion Criteria: * Body weight (at screening): ≥50.0 kg and \<80.0 kg * Body-mass index (at screening): ≥17.6 and \<26.4 kg/m2 \[Body-mass index = Body weight (kg)/(Height (m))2\] * Subject must agree to use contraception consisting of two established forms specified below starting at the time o...