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Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin

NCT ID: NCT00722956

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

2008-07-31

Study Completion Date

2008-08-31

Brief Summary

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The purpose of the study is to assess the pharmacokinetics of both AZD5672 (steady-state) and atorvastatin (single dose) when co administered in healthy volunteers

Detailed Description

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Conditions

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Healthy Volunteers Pharmacokinetics

Keywords

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atorvastatin 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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1

AZD5672 + atorvastatin

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

100 mg once daily, 10 days

atorvastatin

Intervention Type DRUG

one single dose of 40 mg on day 10

Interventions

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AZD5672

100 mg once daily, 10 days

Intervention Type DRUG

atorvastatin

one single dose of 40 mg on day 10

Intervention Type DRUG

Other Intervention Names

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Lipitor®

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures.
* 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 atorvastatin (or other statins) or previous complications to atorvastatin 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

London, , United Kingdom

Site Status

Countries

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Sweden United Kingdom

Other Identifiers

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EudraCt nr 2008-001725-33

Identifier Type: -

Identifier Source: secondary_id

D1710C00025

Identifier Type: -

Identifier Source: org_study_id