NCT04755075

Surufatinib Hepatic Impairment Study

A Phase 1 Study To Assess The Effect Of Hepatic 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 – 75 Years
• Healthy volunteers: Accepted

Summary

An open-label, multicenter, single-dose, single-period, sequential study to determine the effect of hepatic impairment on the PK of surufatinib.

Detailed description

This is a phase 1, open-label, multicenter, single-dose, single-period, sequential study with the primary objective of determining the effect of moderate and mild hepatic impairment on the PK of surufatinib. The secondary objective is to evaluate the safety in subjects with moderate and mild (if enrolled) hepatic impairment and subjects with normal hepatic function.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Surufatinib	Subjects to receive Surufatinib 250 mg on Day 1
DRUG	Surufatinib	Subjects to receive Surufatinib 250 mg on Day 1

Timeline

• Start date: 2021-02-12
• Primary completion: 2021-10-11
• Completion: 2021-10-11
• First posted: 2021-02-15
• Last updated: 2022-08-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study