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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03750565 | Multiple Dose Ethnobridging PK Study in Healthy Subjects | PHASE1 | COMPLETED | 60 | — | — | Nov 27, 2018 | Feb 13, 2019 | Jan 14, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. |
| Cohort 2 | EXPERIMENTAL | Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. |
| Cohort 3 | EXPERIMENTAL | Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. |
| Cohort 4 | EXPERIMENTAL | Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. |
| Name | Type | Description |
|---|---|---|
| TD-1473 - Dose A | DRUG | oral capsule/tablet, QD |
| TD-1473 - Dose B | DRUG | oral capsule/tablet, QD |
| TD-1473 - Dose C | DRUG | oral capsule/tablet, QD |
| Placebo | DRUG | oral capsule/tablet, QD |
Inclusion Criteria: For All subjects: * Male or female between 18 to 55 years old * Female subjects must have documentation of a negative serum pregnancy test, * Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly efficient birth control method...