Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin

This study has been completed.

First Received: July 24, 2008 Last Updated: March 5, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00722956

Purpose

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

Condition	Intervention	Phase
Healthy Volunteers Pharmacokinetics	Drug: AZD5672 Drug: atorvastatin	Phase I

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Phase I, Single Centre, Open-Label Study to Assess the Pharmacokinetics of Both AZD5672 (Steady-State) and Atorvastatin (Single Dose) When Co Administered in Healthy Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PK variables [ Time Frame: Frequent sampling occasions during study periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment periods ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	July 2008
Study Completion Date:	October 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD5672 + atorvastatin	Drug: AZD5672 100 mg once daily, 10 days Drug: atorvastatin one single dose of 40 mg on day 10

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722956

Locations

United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Rod Hepburn	AstraZeneca R&D, Charnwood, UK
Principal Investigator:	Maura Fallon	PAREXEL Clinical Pharmacology Research Unit

More Information

No publications provided

Responsible Party:	AstraZeneca R&D Alderely Park ( Mark Layton, MD, PhD, Medical Science Director )
Study ID Numbers:	D1710C00025, EudraCt nr 2008-001725-33
Study First Received:	July 24, 2008
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00722956 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

atorvastatin
AZD5672

Study placed in the following topic categories:

Antimetabolites
Antilipemic Agents
Anticholesteremic Agents

Healthy
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Atorvastatin

ClinicalTrials.gov processed this record on May 07, 2009