NCT01955304

Food Effect Study of Single Dose of Fruquintinib (HMPL-013) in Healthy Subjects

A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Fruquintinib (HMPL-013) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of 4mg fruquintinib in normal healthy subjects.

Detailed description

This study will be an open-label, randomized, two-period, crossover PK food effect study of fruquintinib administered orally at 4mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study. For each of 2 study periods, subjects will be admitted to the clinical research unit (CRU) on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 4 mg fruquintinib in either the fasted or fed state. Subjects will remain at the CRU for at least 120 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring. Subjects will return to the CRU for safety assessment for up to 336 hours postdose.

Conditions

• Food Effect of Fruquintinib in Health Subjects

Interventions

Type	Name	Description
DRUG	fruquintinib	Fruquintinib 4 mg capsule, 2 discrete single doses separated by 2-weeks

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2013-10-07
• Last updated: 2020-02-17

Locations

1 site across 1 country: China