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A Healthy Subject Study With Z-360 and Placebo

NCT ID: NCT01776463

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Conditions

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Healthy Volunteers

Keywords

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Z-360 Japanese pK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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Z-360

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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

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Zeria Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eri Sato, MD

Role: PRINCIPAL_INVESTIGATOR

Sumida

Locations

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Sumida

Sumida-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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01A10101

Identifier Type: -

Identifier Source: org_study_id