NCT04372394

A Study to Assess the Effect of a High Fat Meal on Surufatinib in Healthy Subjects

A Phase 1, Two Period Crossover Study to Assess the Effect of a High Fat Meal on the Pharmacokinetics of Surufatinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (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 26 healthy male or female subjects. Subjects will be randomly assigned to either receive a single dose of surufatinib with food in period 1, then without food in period 2, or vice-versa.

Detailed description

This study will be a single center, open label, randomized crossover, 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows: * Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8 * Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	surufatinib	Surufatinib: 300 mg as a single dose on Days 1 and 8 with or without food

Timeline

• Start date: 2020-08-14
• Primary completion: 2020-10-31
• Completion: 2021-03-02
• First posted: 2020-05-04
• Last updated: 2021-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study