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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03071770 | Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects | PHASE1 | COMPLETED | 60 | — | — | Mar 31, 2017 | Sep 6, 2017 | Jan 11, 2018 | 1 | United States |
AG-120 Area Under the Curve
AG-120 Maximum Plasma Concentration
| Arm | Type | Description |
|---|---|---|
| ivosidenib (AG-120) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ivosidenib (AG-120) | DRUG | A single-dose of ivosidenib (AG-120) administered in healthy Japanese and Caucasian subjects |
Inclusion Criteria: * Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years. * Applicable to Caucasian Subjects Only: Non-Japanese subjects must be Caucas...