NCT01776463

A Healthy Subject Study With Z-360 and Placebo

A Single Centre, Randomized, Double-blind, Ascending Dose, Placebo-controlled, and Food Effect Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Z-360 and Placebo in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Zeria Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.

Detailed description

This is a single centre, randomized, double-blind, placebo-controlled, parallel-group, and food effect study.This is three parts study. The purpose of the first part (Part 1) is the evaluation of the safety, tolerability, and pharmacokinetics after single ascending doses of Z-360.The second part (Part 2 ) is the evaluation of the pharmacokinetics of food effect of Z-360.The third part (Part 3) is the evaluation of the safety, tolerability, and pharmacokinetics after multiple ascending doses of Z-360.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Z-360
DRUG	placebo

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-04-01
• Completion: 2013-07-01
• First posted: 2013-01-28
• Last updated: 2013-10-01

Locations

1 site across 1 country: Japan