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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03350373 | Clinical Pharmacology of FYU-981 (Final Formulation) | PHASE1 | COMPLETED | 12 | — | — | Nov 6, 2017 | Nov 29, 2017 | Dec 12, 2017 | 1 | Japan |
T1/2: Elimination half-life of plasma concentration
| Arm | Type | Description |
|---|---|---|
| Fasted dosing followed by fed dosing | EXPERIMENTAL | Dosing of FYU-981 in the fasted state followed by fed dosing |
| Fed dosing followed by fasted dosing | EXPERIMENTAL | Dosing of FYU-981 in the fed state followed by fasted dosing |
| Name | Type | Description |
|---|---|---|
| FYU-981 | DRUG | Single administration of FYU-981 under Fasted and fed conditions in the morning. |
Inclusion Criteria: * Japanese healthy adult subjects * Body mass index: \>=18.5 and \<25.0 Exclusion Criteria: * Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study