AZD1981 Midazolam CYP4503A Induction Study

AstraZeneca28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Male Volunteer

Interventions

AZD1981DRUG

oral tablets during 14 consecutive days.

MidazolamDRUG

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

PK samples for both AZD1981 and Midazolam.

Time frame: 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

Time frame: Taken at baseline and after steady state of AZD1981

Safety variables (adverse events and laboratory safety lab)

Time frame: Adverse events taken during study and safety lab at a few time points

Data from ClinicalTrials.gov

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