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
Overview
- Phase
- Phase 1
- Intervention
- Z-360
- Conditions
- Healthy Volunteers
- Sponsor
- Zeria Pharmaceutical
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
Z-360
1)Single dose study (60, 120, 240, 480, 720mg), 2)Food effect study(120mg), 3)Multiple doses study(120, 240mg (BID))
Intervention: Z-360
Placebo
1)Single dose study, 2)Multiple doses study
Intervention: placebo
Outcomes
Primary Outcomes
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
- To evaluate the pharmacokinetics of single and multiple doses of Z-360 in healthy subjects(up to 6 weeks)