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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02320409 | A Food Effect Phase I Study of the Sulfatinib in Healthy Subjects (HMPL-012) | PHASE1 | COMPLETED | 24 | — | — | Dec 1, 2014 | Apr 1, 2015 | May 8, 2020 | 1 | China |
| NCT03627520 | A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib | EARLY_PHASE1 | COMPLETED | 6 | — | — | Apr 2, 2018 | Jul 1, 2018 | Apr 23, 2019 | 1 | China |
Area Under Curve (AUC), both from time zero to time with last observation and from time zero to infinity;;Maximum plasma concentration (Cmax);Time to reach the Cmax (Tmax);elimination half-life
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
| Arm | Type | Description |
|---|---|---|
| Sulfatinib ,after general diet | EXPERIMENTAL | First cycle, single oral Sulfatinib after general diet intake; Second cycle, Sulfatinib before general diet intake. |
| Sulfatinib, before general diet | EXPERIMENTAL | First cycle, single oral Sulfatinib before general diet intake;Second cycle,single oral Sulfatinib after general diet intake |
| [14C]Sulfatinib | OTHER | This is a single center and single dose in 6 volunteers. Subject would take a suspension containing 300 mg of Sulfatinib (containing about 100 μCi of radioactivity) within 1 hour after standard breakfast. |
| Name | Type | Description |
|---|---|---|
| Sulfatinib | DRUG | 250mg Sulfatinib ,single dose,oral |
| [14C]Sulfatinib | DRUG | 300 mg Sulfatinib with 100 µCi \[14C\] |
Inclusion Criteria: * Males , between 18 and 55 years of age, inclusive. * Body mass index (BMI) within the range of 20 to 30 kg/m2, inclusive. * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs. * Adequate hep...