A Healthy Subject Study With Z-360 and Placebo

September 30, 2013 updated by: Zeria Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Sumida-ku, Tokyo, Japan, 130-0004
        • Sumida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests)
Time Frame: up to 6 weeks
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
Time Frame: up to 6 weeks
pK (AUC, Cmax, Tmax, T1/2, MRT, CL/F, V/F)
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeria Pharmaceutical

Investigators

  • Principal Investigator: Eri Sato, MD, Sumida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01A10101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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