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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04510649 | Surufatinib DDI With a PPI and a CYP3A Inducer | PHASE1 | COMPLETED | 28 | — | — | Jul 9, 2020 | Mar 2, 2021 | Jun 18, 2021 | 1 | United States |
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity (if data permit)
Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration
| Arm | Type | Description |
|---|---|---|
| Surufatinib and Rabeprazole (Part A) | EXPERIMENTAL | Part A: Surufatinib 300 mg on study days 1 and 11 Rabeprazole 40 mg on study days 5 - 11 |
| Surufatinib and Rifampin (Part B) | EXPERIMENTAL | Part B: Surufatinib 300 mg on study days 1 and 12 Rifampin 600 mg on study days 5-15 |
| Name | Type | Description |
|---|---|---|
| Part A | DRUG | in Part A, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 11 and receive Rabeprazole 30 mg single dose on study days 5 through 11 |
| Part B | DRUG | in Part B, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 12 and receive Rifampin 600 mg single dose on study days 5 through 16 |
Inclusion Criteria * Non-smoking, healthy male or female between the ages of 18 and 55 years (inclusive) * Body mass index (BMI) \> 18 and ≤ 29 kg/m2 * Females must be of non-childbearing potential or surgically sterile * Males who have not had a successful vasectomy and are partners of women of ch...