Drug Interaction Study Between AZD3480 and Cytochrome P450

Phase 1

Completed

• Conditions: Metabolism; Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: AZD3480; Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

• Registration Number: NCT00692510
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-25
• Last Update Posted: 2008-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

• Provision of signed written informed consent
• Clinically normal physical findings and laboratory values

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Exclusion Criteria

• Clinically significant illness or clinically relevant trauma within three weeks before the first dose
• History of clinically significant disease
• Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo + cocktail
2	Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)	Placebo + cocktail
1	AZD3480	AZD3480 + cocktail
1	Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)	AZD3480 + cocktail

Primary Outcome Measures

Name	Time	Method
PK variables	Frequent sampling occasions during the treatment periods

Secondary Outcome Measures

Name	Time	Method
Safety variables (adverse events, blood pressure, pulse, safety lab)	During the whole treatment period

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden