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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: AZD9056 + simvastatin

Drug: simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00736606

D1520C00008

EudraCt nr 2008-003626-41

Details and patient eligibility

About

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

Enrollment

12 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).