Status:
COMPLETED
AZD1981 Midazolam CYP4503A Induction Study
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Male Volunteer
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to investigate if the exposure of midazolam is clinically significantly changed by 14 days of exposure to AZD1981 through possible enzyme induction of CYP3A.
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)
Exclusion
- 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 influence the result of the study, or the subject´s ability to participate
- Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00859352
Start Date
March 1 2009
End Date
April 1 2009
Last Update
April 10 2009
Active Locations (1)
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1
Research Site
Uppsala, Sweden