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
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Jan 2013
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 15, 2013
CompletedFirst Posted
Study publicly available on registry
January 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedOctober 1, 2013
September 1, 2013
3 months
January 15, 2013
September 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
General safety and tolerability endpoints: (Adverse events, Vital signs, 12-lead ECG and clinical laboratory safety tests)
up to 6 weeks
Secondary Outcomes (1)
To evaluate the pharmacokinetics of single and multiple doses of Z-360 in healthy subjects
up to 6 weeks
Study Arms (2)
Z-360
EXPERIMENTAL1)Single dose study (60, 120, 240, 480, 720mg), 2)Food effect study(120mg), 3)Multiple doses study(120, 240mg (BID))
Placebo
PLACEBO COMPARATOR1)Single dose study, 2)Multiple doses study
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sumida
Sumida-ku, Tokyo, 130-0004, Japan
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Eri Sato, MD
Sumida
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2013
First Posted
January 28, 2013
Study Start
January 1, 2013
Primary Completion
April 1, 2013
Study Completion
July 1, 2013
Last Updated
October 1, 2013
Record last verified: 2013-09