A Healthy Subject Study With Z-360 and Placebo

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Z-360; Drug: placebo

• Registration Number: NCT01776463
• Lead Sponsor: Zeria Pharmaceutical

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-28
• Primary Completion: 2013-04
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

1. Healthy male subjects between 20 to 49 years of age inclusive
2. Body mass index (BMI) within the range 17.6 to 26.4 kg/m2 inclusive
3. The subject is capable of giving written informed consent prior to admission into this study

Exclusion Criteria

1. History or presence of drug hypersensitivity, drug dependence, narcotic dependence or alcohol dependence
2. History or presence disease of digestive, liver, kidney, blood, cardiovascular, neuropsychiatric which may affect participation or results of this study
3. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, HIV antigen antibody or Serological test for syphilis
4. Use of any medication within 1 week prior to dosing
5. Received any investigational drugs with new active ingredients within 16 weeks prior to dosing the study or received any investigational drugs in other clinical studies within 12 weeks
6. Whole blood collection exceeding 200 mL within 4 weeks, apheresis within 2 weeks, or blood withdrawal exceeding 400 mL within 12 weeks (blood donation, etc) prior to dosing
7. Others, patients who are unfit for the study as determined by the attending physician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Z-360	Z-360	1)Single dose study (60, 120, 240, 480, 720mg), 2)Food effect study(120mg), 3)Multiple doses study(120, 240mg (BID))
Placebo	placebo	1)Single dose study, 2)Multiple doses study

Primary Outcome Measures

Name	Time	Method
General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests)	up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of single and multiple doses of Z-360 in healthy subjects	up to 6 weeks	pK (AUC, Cmax, Tmax, T1/2, MRT, CL/F, V/F)

Trial Locations

Locations (1)

Sumida; 🇯🇵 Sumida-ku, Tokyo, Japan