Determine the Effect of Multiple Doses of AZD7325, CYP Study

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: AZD7325; Drug: Midazolam; Drug: Caffeine

• Registration Number: NCT00790114
• Lead Sponsor: AstraZeneca

Brief Summary

To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine \[3-desmethyl\] metabolite).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-11
• Study First Submitted: 2008-11-11
• Study First Submitted QC: 2008-11-12
• Last Update Submitted: 2008-11-12
• Study First Posted: 2008-11-13
• Last Update Posted: 2008-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

• Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.
• Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD7325	-
1	Midazolam	-
1	Caffeine	-

Primary Outcome Measures

Name	Time	Method
To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).	Blood samples will be taken during the study.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of repeated doses of AZD7325 in combination with midazolam and caffeine.	Blood samples will be taken during the study.
Evaluation of the pharmacodynamic effects of AZD7325	Test batteries will be performed at specified times both before and following study drug administration.
To evaluate the pharmacokinetics of AZD7325	Blood samples will be taken on Days 1, 11 and 12.