Status:
COMPLETED
AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese s...
Eligibility Criteria
Inclusion
- Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
- Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)
- 18 to ≤ 27 kg/m2
Exclusion
- Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study
- Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
- Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00912353
Start Date
May 1 2009
End Date
October 1 2009
Last Update
January 29 2013
Active Locations (1)
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1
Research Site
Gelndale, California, United States