NCT04372407

A Study to Assess the Effect of a Strong CYP3A Inhibitor, on Surufatinib in Healthy Subjects

A Phase 1, Two Period Fixed-sequence Crossover Study to Assess the Effects of Itraconazole, a Strong CYP3A Inhibitor, on the Pharmacokinetics of Surufatinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will be a 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in Period 2.

Detailed description

This study will be a single center, open label, fixed-sequence crossover, 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Surufatinib	Surufatinib: 200 mg as single dose on Days 1 and 9
DRUG	Itraconazole	Itraconazole: 200 mg BID on Day 5, then 200 mg QD on Days 6 to 14

Timeline

• Start date: 2020-07-09
• Primary completion: 2020-09-29
• Completion: 2021-01-19
• First posted: 2020-05-04
• Last updated: 2021-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study