NCT00859352

AZD1981 Midazolam CYP4503A Induction Study

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Volunteer

Interventions

Type	Name	Description
DRUG	AZD1981	oral tablets during 14 consecutive days.
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.

Timeline

• Start date: 2009-03-01
• Completion: 2009-04-01
• First posted: 2009-03-11
• Last updated: 2009-04-10

Locations

1 site across 1 country: Sweden