Status:
COMPLETED
AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Ja...
Eligibility Criteria
Inclusion
- Body mass index (BMI): 18 to 27 kg/m 2
- Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
- Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.
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 prescription medication within 14 days of Day 1
- Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
- Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00785915
Start Date
November 1 2008
End Date
March 1 2009
Last Update
October 13 2014
Active Locations (2)
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1
Research Site
Glendale, California, United States
2
Research Site
Baltimore, Maryland, United States