AZD1981 Midazolam CYP4503A Induction Study

NCT00859352 — Phase 1, Completed, 28 participants, AstraZeneca

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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.

Registry	NCT00859352
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, basic science
Enrollment	28 (Estimated)
Sponsor	AstraZeneca (Industry)
Conditions	Healthy Male Volunteer
Interventions	AZD1981, Midazolam (Drug)
Dates	start 2009-03-01, completion 2009-04-01, first posted 2009-03-11, last updated 2009-04-10
Locations	1 site in Sweden

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: AZD1981; Drug: Midazolam	AZD1981 100mg and Midazolam
2	Experimental	Drug: Midazolam	AZD1981 500mg and Midazolam

AZD1981 (Drug): oral tablets during 14 consecutive days.
Midazolam (Drug): 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.

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: Male, ages: 18 Years to 55 Years, 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

+Locations (1)

Facility	City	Country	Status
Research Site	Uppsala	Sweden

+Investigators

Eva Pettersson, Study director, AstraZeneca R&D, Lund, Sweden
Aslak Rautio, Principal investigator, Quintiles Hermelinen AB, Luleå, Sweden