AZD1981 Midazolam CYP4503A Induction Study

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Male Volunteer

Treatments

Drug: Midazolam

Drug: AZD1981

Study type

Interventional

Funder types

Industry

Identifiers

NCT00859352

D9831C00008

EudraCT No. 2008-008224-32

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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