Status:
COMPLETED
Assessing the Safety and Tolerability of a Single IV Dose of AZD9742 in Healthy Elderly Male and Female Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Tolerability
Healthy
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
The aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals.
Eligibility Criteria
Inclusion
- Male and female volunteers at age of 65 years or older with suitable veins for cannulation or repeated venipuncture, in good health (based on medical history and physical examination and clinical laboratory tests) as judged by the investigator.
- Female volunteers must be postmenopausal (cessation of regular menses for 12 months and a follicle stimulating hormone level of more than 40IU/L abd estradiol of less than 20ng/mL.
- Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
Exclusion
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01154621
Start Date
June 1 2010
End Date
July 1 2010
Last Update
August 3 2010
Active Locations (1)
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1
Research Site
Springfield, Missouri, United States