A Healthy Subject Study With Z-360 and Placebo

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Z-360
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between 20 to 49 years of age inclusive Body mass index (BMI) within the range 17.6 to 26.4 kg/m2 inclusive The subject is capable of giving written informed consent prior to admission into this study Exclusion Criteria: History or presence of drug hypersensitivity, drug dependence, narcotic dependence or alcohol dependence History or presence disease of digestive, liver, kidney, blood, cardiovascular, neuropsychiatric which may affect participation or results of this study Positive test for Hepatitis B surface antigen, Hepatitis C antibody, HIV antigen antibody or Serological test for syphilis Use of any medication within 1 week prior to dosing 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 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 Others, patients who are unfit for the study as determined by the attending physician

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Z-360<br>1)Single dose study (60, 120, 240, 480, 720mg), 2)Food effect study(120mg), 3)Multiple doses study(120, 240mg (BID)) | Drug: Z-360<br> <br> |
| Placebo Comparator: Placebo<br>1)Single dose study, 2)Multiple doses study | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests) |  | up to 6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Z-360, Japanese, pK