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.

AstraZeneca1 site in 1 country28 target enrollmentMarch 2009

ConditionsHealthy Male Volunteer

InterventionsAZD1981 Midazolam

DrugsAZD1981 Midazolam

Overview

Phase: Phase 1
Intervention: AZD1981
Conditions: Healthy Male Volunteer
Sponsor: AstraZeneca
Enrollment: 28
Locations: 1
Primary Endpoint: PK samples for both AZD1981 and Midazolam.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

April 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Arms & Interventions

1

AZD1981 100mg and Midazolam

Intervention: AZD1981

1

AZD1981 100mg and Midazolam

Intervention: Midazolam

2

AZD1981 500mg and Midazolam

Intervention: Midazolam

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(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)