AZD1981 Midazolam CYP4503A Induction Study

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy Male Volunteer

Intervention / Treatment
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* Drug: AZD1981
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1981 100mg and Midazolam | Drug: AZD1981<br>* oral tablets during 14 consecutive days.<br>Drug: Midazolam<br>* 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.<br>|
| Experimental: 2<br>AZD1981 500mg and Midazolam | Drug: Midazolam<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |