Surufatinib Renal Impairment Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Renal Impairment
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 79 years
- Gender
- Both males and females
Description
An open-label, multicenter, single-dose, single-period, sequential study with the primary objective of assessing the effect of moderate renal impairment on the PK of surufatinib following administration of 300mg single oral dose. The secondary objective is to evaluate the safety in subjects with mod...
An open-label, multicenter, single-dose, single-period, sequential study with the primary objective of assessing the effect of moderate renal impairment on the PK of surufatinib following administration of 300mg single oral dose. The secondary objective is to evaluate the safety in subjects with moderate renal impairment and subjects with normal renal function following a single oral dose of 300mg surufatinib. Approximately 16 subjects will be enrolled
Tracking Information
- NCT #
- NCT04755088
- Collaborators
- Not Provided
- Investigators
- Not Provided
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