AZD1981 Midazolam CYP4503A Induction Study

Healthy Male Volunteer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859352
• Other study ID #: D9831C00008
• Secondary ID: EudraCT No. 2008
• Status: Completed
• Phase: Phase 1
• First received: March 10, 2009
• Last updated: April 9, 2009
• Start date: March 2009
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Male Volunteer

Intervention

Drug:
• AZD1981
oral tablets during 14 consecutive days.
• 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.

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sampling of 4ß-hydroxycholesterol		Taken at baseline and after steady state of AZD1981	No
Secondary	Safety variables (adverse events and laboratory safety lab)		Adverse events taken during study and safety lab at a few time points	No