A Healthy Subject Study With Z-360 and Placebo | NCT01776463

Studies
A Healthy Subject Study With Z-360 and Placebo

NCT01776463

Sponsor

Zeria Pharmaceutical

Status

Completed

Last Update Posted

Oct 1, 2013Estimated

Enrollment

43Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Z-360
placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jan 15, 2013

First Submission Date that Met QC Criteria

Jan 22, 2013

First Posted Date

Jan 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2013

Last Update Posted Date

Oct 1, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Z-360	Experimental	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	Placebo Comparator	1)Single dose study, 2)Multiple doses study	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Z-360	Drug		Z-360
placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided