Status:
TERMINATED
AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-rel...
Eligibility Criteria
Inclusion
- Healthy Japanese and Caucasian male subjects 20 to 45 years of age inclusive
- Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2
Exclusion
- Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator
- History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator
- Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00935025
Start Date
July 1 2009
End Date
November 1 2009
Last Update
December 7 2010
Active Locations (2)
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1
Research Site
Glendale, California, United States
2
Research Site
Baltimore, Maryland, United States