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Drug Interaction Study Between AZD3480 and Cytochrome P450

NCT ID: NCT00692510

Last Updated: 2008-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-09-30

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.

Detailed Description

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Conditions

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Metabolism Alzheimer's Disease

Keywords

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AZD3480 Cocktail caffeine bupropion omeprazole midazolam rosiglitazone metabolism Drug Drug Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AZD3480 + cocktail

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

Capsule, oral, dose once daily, 7 days

Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

Intervention Type DRUG

Cocktail mix which contains the following:

CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin)

single dose of mix

2

Placebo + cocktail

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule, oral, dose once daily, 7 days

Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

Intervention Type DRUG

Cocktail mix which contains the following:

CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin)

single dose of mix

Interventions

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AZD3480

Capsule, oral, dose once daily, 7 days

Intervention Type DRUG

Placebo

Capsule, oral, dose once daily, 7 days

Intervention Type DRUG

Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

Cocktail mix which contains the following:

CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin)

single dose of mix

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Södertälje, Sweden

Principal Investigators

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Hans-Göran Hårdemark, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Södertälje, Sweden

Cyril Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

ICON Development Solutions Manchester, Manchester Science Park, Manchester, UK

Locations

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Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCt nr 2007-002456-10

Identifier Type: -

Identifier Source: secondary_id

D3690C00016

Identifier Type: -

Identifier Source: org_study_id