Status:
COMPLETED
A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and simvastatin (single dose) when co-administered in healthy volunteers
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures.
- Male or female healthy subjects. Females should not be of childbearing potential
- Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results
Exclusion
- 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 may influence the results of the study, or the subject's ability to participate
- Known allergy to simvastatin (or other statins) or previous complications to simvastatin therapy.
- Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00736606
Start Date
August 1 2008
End Date
September 1 2008
Last Update
December 2 2010
Active Locations (1)
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1
Research Site
Berlin, Germany