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Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00722956
First received: July 24, 2008
Last updated: November 30, 2010
Last verified: November 2010
History of Changes

July 24, 2008
November 30, 2010
July 2008
August 2008   (final data collection date for primary outcome measure)
PK variables [ Time Frame: Frequent sampling occasions during study periods ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00722956 on ClinicalTrials.gov Archive Site
Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment periods ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin
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

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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Healthy Volunteers
  • Pharmacokinetics
  • Drug: AZD5672
    100 mg once daily, 10 days
  • Drug: atorvastatin
    one single dose of 40 mg on day 10
    Other Name: Lipitor®
Experimental: 1
AZD5672 + atorvastatin
Interventions:
  • Drug: AZD5672
  • Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2008
August 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00722956
D1710C00025, EudraCt nr 2008-001725-33
No
Mark Layton, MD, PhD, Medical Science Director, AstraZeneca R&D Alderely Park
AstraZeneca
Not Provided
Study Director: Rod Hepburn AstraZeneca R&D, Charnwood, UK
Principal Investigator: Maura Fallon PAREXEL Clinical Pharmacology Research Unit
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP