Healthy Male Volunteer
Conditions
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.
Interventions
DRUGAZD1981
oral tablets during 14 consecutive days.
DRUGMidazolam
Each subject will receive two single doses of 7.5 mg midazolam given as oral solution. The Midazolam dose will be given on Day 1 and on day 16.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK samples for both AZD1981 and Midazolam. | Intense PK-sampling during 3 pre-defined study days for PK profiling and some sampling throughout the whole study period for confirmatory purposes |
Secondary
| Measure | Time frame |
|---|---|
| Sampling of 4β-hydroxycholesterol | Taken at baseline and after steady state of AZD1981 |
| Safety variables (adverse events and laboratory safety lab) | Adverse events taken during study and safety lab at a few time points |
Countries
Sweden
Outcome results
None listed