A Healthy Subject Study With Z-360 and Placebo

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01776463

Enrollment

Registered

2013-01-28

Start date

2013-01-31

Completion date

2013-07-31

Last updated

2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Z-360, Japanese, pK

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.

Interventions

DRUGZ-360

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 49 Years

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

Design outcomes

Primary

Measure	Time frame
General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests)	up to 6 weeks

Secondary

Measure	Time frame	Description
To evaluate the pharmacokinetics of single and multiple doses of Z-360 in healthy subjects	up to 6 weeks	pK (AUC, Cmax, Tmax, T1/2, MRT, CL/F, V/F)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026