Surufatinib DDI With a PPI and a CYP3A Inducer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
This study will be a single center, open-label, 2 part, 2 period fixed-sequence crossover study to be conducted with 28 healthy male and female subjects (part A and part B). Subjects will be enrolled in either part A or part B. In Part A, subjects will be administered surufatinib alone in treatment ...
This study will be a single center, open-label, 2 part, 2 period fixed-sequence crossover study to be conducted with 28 healthy male and female subjects (part A and part B). Subjects will be enrolled in either part A or part B. In Part A, subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rabeprazole in treatment Period 2. In Part B, subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rifampin in treatment Period 2. PK samples will be collected through out both study periods.Subjects will be confined in the clinic from check-in on Day -1 through the end-of study visit on Day 15 (part A) and Day 16 (part B).
Tracking Information
- NCT #
- NCT04510649
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Youngiun Kim, MD WCCT Global Inc.
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