A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD9056 + simvastatin; Drug: simvastatin

• 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

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-02

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