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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00736606
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
1
Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
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
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Period 1

simvastatin

Drug: simvastatin
One single dose of 40mg
Other Names:
  • 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 Names:
  • Zocor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PK variables [Frequent sampling occasions during study periods]

    Secondary Outcome Measures

    1. Safety variables (adverse events, blood pressure, pulse, safety lab) [During the whole treatment periods]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00736606
    Other Study ID Numbers:
    • D1520C00008
    • EudraCt nr 2008-003626-41
    First Posted:
    Aug 18, 2008
    Last Update Posted:
    Dec 2, 2010
    Last Verified:
    Nov 1, 2010
    Keywords provided by , ,
    simvastatin
    AZD5672
    Additional relevant MeSH terms:
    Simvastatin

    Study Results

    No Results Posted as of Dec 2, 2010