A Healthy Subject Study With Z-360 and Placebo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01776463
First received: January 15, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Z-360
Drug: placebo
Phase 1

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

Further study details as provided by Zeria Pharmaceutical:

Primary Outcome Measures:
  • General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics of single and multiple doses of Z-360 in healthy subjects [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    pK (AUC, Cmax, Tmax, T1/2, MRT, CL/F, V/F)


Enrollment: 43
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776463

Locations
Japan
Sumida
Sumida-ku, Tokyo, Japan, 130-0004
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
Principal Investigator: Eri Sato, MD Sumida
  More Information

No publications provided

Responsible Party: Zeria Pharmaceutical
ClinicalTrials.gov Identifier: NCT01776463     History of Changes
Other Study ID Numbers: 01A10101
Study First Received: January 15, 2013
Last Updated: September 30, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Zeria Pharmaceutical:
Z-360
Japanese
pK

ClinicalTrials.gov processed this record on August 20, 2014