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A Healthy Subject Study With Z-360 and Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01776463
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : October 1, 2013
Information provided by (Responsible Party):
Zeria Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Z-360 Drug: placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : July 2013

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

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

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01776463

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

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Responsible Party: Zeria Pharmaceutical Identifier: NCT01776463     History of Changes
Other Study ID Numbers: 01A10101
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013
Keywords provided by Zeria Pharmaceutical: