AZD1981 Midazolam CYP4503A Induction Study

Phase 1

Completed

• Conditions: Healthy Male Volunteer
• Interventions: Drug: AZD1981; Drug: Midazolam

• Registration Number: NCT00859352
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Status Verified: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-09
• Last Update Posted: 2009-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1981	AZD1981 100mg and Midazolam
2	Midazolam	AZD1981 500mg and Midazolam
1	Midazolam	AZD1981 100mg and Midazolam

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden