NCT02017236

A Food Effect Phase I Study of the Volitinib in Healthy Subjects

A Single Center, Open-label, Randomized, Four-Sequence, Four-period Crossover Study to Investigate Food Effect on the Pharmacokinetics of Single Dose of Volitinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 600 mg Volitinib and its two major metabolites in healthy subjects.

Detailed description

The purpose of this study is to evaluate to determine the effect of food on the PK( pharmacokinetics) of a single dose of 600 mg Volitinib and its two major metabolites in healthy subjects and to assess the safety and tolerability of single doses of 600mg in healthy subjects.This study will be an open-label, randomized, four-period, crossover PK food effect study of Volitinib administered orally at 600 mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study,there will be 4 treatments,2 weeks follow-up.

Conditions

• Food Effect
• Health Subjects

Interventions

Type	Name	Description
DRUG	Volitinib	600mg Volitinib ,single dose,oral

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2013-12-20
• Last updated: 2019-05-14

Locations

1 site across 1 country: China