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NCT Number: NCT01776463

A Healthy Subject Study With Z-360 and Placebo

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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sumida

Sumida-ku, Tokyo, 130-0004, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Z-360

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2013
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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