Status:
COMPLETED
Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.
Eligibility Criteria
Inclusion
- first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
- Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
Exclusion
- History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
- Participation in another study within 12 weeks before the first administration of the investigational product.
- Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00738959
Start Date
June 1 2008
End Date
October 1 2008
Last Update
October 29 2008
Active Locations (1)
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1
Research Site
London, United Kingdom