A Healthy Subject Study With Z-360 and Placebo

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776463
• Other study ID #: 01A10101
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2013
• Last updated: September 30, 2013
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Z-360

• placebo

Locations

Country	Name	City	State
Japan	Sumida	Sumida-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests)		up to 6 weeks	Yes
Secondary	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	No