AZD1981 Midazolam CYP4503A Induction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-04-30

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.

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Detailed Description

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Conditions

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Healthy Male Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AZD1981 100mg and Midazolam

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

oral tablets during 14 consecutive days.

Midazolam

Intervention Type 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.

2

AZD1981 500mg and Midazolam

Group Type EXPERIMENTAL

Midazolam

Intervention Type 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.

Interventions

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AZD1981

oral tablets during 14 consecutive days.

Intervention Type DRUG

Midazolam

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes