NCT04755088

Surufatinib Renal Impairment Study

A Phase 1 Study To Assess The Effect Of Moderate Renal Impairment On The Pharmacokinetics Of Surufatinib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

An open-label, multicenter, single-dose, single-period, sequential study to assess the effect of moderate renal impairment on the pharmacokinetics of surufatinib.

Detailed 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 moderate renal impairment and subjects with normal renal function following a single oral dose of 300mg surufatinib. Approximately 16 subjects will be enrolled

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Surufatinib	Subjects to receive Surufatinib 300mg on Day 1
DRUG	Surufatinib	Subjects to receive Surufatinib 300mg on Day 1

Timeline

• Start date: 2021-02-12
• Primary completion: 2021-08-21
• Completion: 2021-08-21
• First posted: 2021-02-15
• Last updated: 2022-11-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study