A Healthy Subject Study With Z-360 and Placebo

NCT ID: NCT01776463

Last Updated: 2013-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-07-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Z-360

1)Single dose study (60, 120, 240, 480, 720mg), 2)Food effect study(120mg), 3)Multiple doses study(120, 240mg (BID))

Group Type: EXPERIMENTAL

Z-360

Intervention Type: DRUG

Placebo

1)Single dose study, 2)Multiple doses study

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Z-360

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zeria Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eri Sato, MD

Role: PRINCIPAL_INVESTIGATOR

Sumida

Locations

Sumida

Sumida-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

01A10101

Identifier Type: -

Identifier Source: org_study_id