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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736606
First Posted: August 18, 2008
Last Update Posted: December 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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

Condition Intervention Phase
Healthy Volunteers Drug: simvastatin Drug: AZD9056 + simvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Open-Label Study to Assess the Pharmacokinetics of Both AZD9056 (Steady State) and Simvastatin (Single Dose) When Co-Administered in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during study periods ]

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment periods ]

Estimated Enrollment: 12
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1
simvastatin
Drug: simvastatin
One single dose of 40mg
Other Name: Zocor
Experimental: Period 2
simvastatin + AZD9056
Drug: AZD9056 + simvastatin
AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7
Other Name: Zocor

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736606


Locations
Germany
Research Site
Berlin, Germany
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

Responsible Party: Mark Layton, MD, PhD, Medical Science Director, AstraZeneca R&D Alderely Park
ClinicalTrials.gov Identifier: NCT00736606     History of Changes
Other Study ID Numbers: D1520C00008
EudraCt nr 2008-003626-41
First Submitted: August 15, 2008
First Posted: August 18, 2008
Last Update Posted: December 2, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
simvastatin
AZD5672

Additional relevant MeSH terms:
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors