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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03068481 | Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease | PHASE1 | COMPLETED | 36 | — | — | Feb 20, 2017 | Aug 13, 2018 | Apr 1, 2019 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| Healthy volunteer part -Single dose | EXPERIMENTAL | Single oral dose of KDT-3594 |
| Healthy volunteer part -Multiple dose | EXPERIMENTAL | Multiple oral doses of KDT-3594 |
| Healthy volunteer part -Placebo | PLACEBO_COMPARATOR | Multiple oral doses of Placebo |
| Patient part -Single dose | EXPERIMENTAL | Single oral dose of KDT-3594 |
| Patient part -Multiple dose | EXPERIMENTAL | Multiple oral doses of KDT-3594 |
| Name | Type | Description |
|---|---|---|
| KDT-3594 | DRUG | Oral administration |
| Placebo | DRUG | Oral administration |
Inclusion Criteria: * Healthy volunteer part * Healthy Japanese males aged 20 to 35 years, inclusive * Patient part * Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria * Patients with Parkinson's disease i...