Status:
COMPLETED
AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteer
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to ...
Eligibility Criteria
Inclusion
- Body mass index (BMI) : 18 to 27 kg/m 2
Exclusion
- Clinically relevant disease and/or abnormalities (past or present)
- Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
- Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
- Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00769899
Start Date
October 1 2008
End Date
March 1 2009
Last Update
March 18 2009
Active Locations (2)
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1
Research Site
Glendale, California, United States
2
Research Site
Baltimore, Maryland, United States