NCT02320409

A Food Effect Phase I Study of the Sulfatinib in Healthy Subjects (HMPL-012)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: Male
• Age: 18 Years – 55 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 250 mg Sulfatinib and its 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 250 mg Sulfatinib and its metabolites in healthy subjects and to assess the safety and tolerability of single doses of 250mg in healthy subjects.This study will be an open-label, randomized, two-period, crossover PK food effect study of Sulfatinib administered orally at 250 mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study,there will be 2 treatments,2 weeks follow-up.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sulfatinib	250mg Sulfatinib ,single dose,oral

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-01-01
• Completion: 2015-04-01
• First posted: 2014-12-19
• Last updated: 2020-05-08

Locations

1 site across 1 country: China