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

NCT ID: NCT00736606

Last Updated: 2010-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Healthy Volunteers

Keywords

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simvastatin AZD5672

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Period 1

simvastatin

Group Type EXPERIMENTAL

simvastatin

Intervention Type DRUG

One single dose of 40mg

Period 2

simvastatin + AZD9056

Group Type EXPERIMENTAL

AZD9056 + simvastatin

Intervention Type DRUG

AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7

Interventions

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simvastatin

One single dose of 40mg

Intervention Type DRUG

AZD9056 + simvastatin

AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7

Intervention Type DRUG

Other Intervention Names

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Zocor Zocor

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Alderely Park

Principal Investigators

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Rod Hepburn

Role: STUDY_DIRECTOR

AstraZeneca R&D, Charnwood, UK

Maura Fallon

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Clinical Pharmacology Research Unit

Locations

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Research Site

Berlin, , Germany

Site Status

Countries

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Sweden Germany

Other Identifiers

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EudraCt nr 2008-003626-41

Identifier Type: -

Identifier Source: secondary_id

D1520C00008

Identifier Type: -

Identifier Source: org_study_id