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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.
Information provided by:
AstraZeneca Identifier:
First received: August 15, 2008
Last updated: November 30, 2010
Last verified: November 2010
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
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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00736606

Research Site
Berlin, Germany
Sponsors and Collaborators
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 Identifier: NCT00736606     History of Changes
Other Study ID Numbers: D1520C00008
EudraCt nr 2008-003626-41
Study First Received: August 15, 2008
Last Updated: November 30, 2010

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 17, 2017