Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of A...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture
- Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the Investigational Product (IP)
- Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg
Exclusion
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History or presence of gastrointestinal, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Abnormal vital signs, after 10 minutes supine rest
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01264250
Start Date
January 1 2011
End Date
May 1 2011
Last Update
May 24 2011
Active Locations (1)
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1
Research Site
Uppsala, Sweden