Drug Interaction Study Between AZD3480 and Cytochrome P450

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

Official Title
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A Phase I, Double Blind, Randomized, Two-Way Cross Over, Single- Centre Study in Healthy CYP2D6 Extensive Metabolizers and Poor Metabolizers to Investigate the Potential of AZD3480 to Inhibit Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 Activity

Conditions
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Metabolism, Alzheimer's Disease

Intervention / Treatment
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* Drug: AZD3480
* Drug: Placebo
* Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed written informed consent Clinically normal physical findings and laboratory values 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD3480 + cocktail | Drug: AZD3480<br>* Capsule, oral, dose once daily, 7 days<br>Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)<br>* Cocktail mix which contains the following: CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin) single dose of mix<br>|
| Placebo Comparator: 2<br>Placebo + cocktail | Drug: Placebo<br>* Capsule, oral, dose once daily, 7 days<br>Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)<br>* Cocktail mix which contains the following: CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin) single dose of mix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during the treatment periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AZD3480, Cocktail, caffeine, bupropion, omeprazole, midazolam, rosiglitazone, metabolism, Drug Drug Interaction