A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT00736606
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- 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 Criteria
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Period 2 AZD9056 + simvastatin simvastatin + AZD9056 Period 1 simvastatin simvastatin
- Primary Outcome Measures
Name Time Method PK variables Frequent sampling occasions during study periods
- Secondary Outcome Measures
Name Time Method Safety variables (adverse events, blood pressure, pulse, safety lab) During the whole treatment periods
Trial Locations
- Locations (1)
Research Site
🇩🇪Berlin, Germany
Research Site🇩🇪Berlin, Germany