A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers
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
2 other identifiers
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Aug 2008
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 15, 2008
CompletedFirst Posted
Study publicly available on registry
August 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedDecember 2, 2010
November 1, 2010
1 month
August 15, 2008
November 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK variables
Frequent sampling occasions during study periods
Secondary Outcomes (1)
Safety variables (adverse events, blood pressure, pulse, safety lab)
During the whole treatment periods
Study Arms (2)
Period 1
EXPERIMENTALsimvastatin
Period 2
EXPERIMENTALsimvastatin + AZD9056
Interventions
AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Berlin, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rod Hepburn
AstraZeneca R&D, Charnwood, UK
- PRINCIPAL INVESTIGATOR
Maura Fallon
PAREXEL Clinical Pharmacology Research Unit
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 15, 2008
First Posted
August 18, 2008
Study Start
August 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 2, 2010
Record last verified: 2010-11