AZD1981 Midazolam CYP4503A Induction Study

A Phase I, Open, Randomised, Non-Comparative, Parallel Group Study of a Potential Cytochrome P450 3A Induction After Repeat Twice Daily Oral Dosing With 100 and 500 mg AZD1981 Tablets for 14 Days to Healthy Male Volunteers With Single Oral Doses of Midazolam 7.5 mg.

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.

Inclusion Criteria:

• 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 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 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