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Drug Interaction Study Between AZD3480 and Cytochrome P450 (Cocktail)

Primary Purpose

Metabolism, Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

AZD3480

Placebo

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

About this trial

This is an interventional basic science trial for Metabolism focused on measuring AZD3480, Cocktail, caffeine, bupropion, omeprazole, midazolam, rosiglitazone, metabolism, Drug Drug Interaction

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

AZD3480 + cocktail

Placebo + cocktail

Outcomes

Primary Outcome Measures

PK variables

Secondary Outcome Measures

Safety variables (adverse events, blood pressure, pulse, safety lab)

Full Information

NCT ID

NCT00692510

First Posted

May 29, 2008

Last Updated

November 25, 2008

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00692510

Brief Title

Drug Interaction Study Between AZD3480 and Cytochrome P450

Acronym

Cocktail

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism, Alzheimer's Disease

Keywords

AZD3480, Cocktail, caffeine, bupropion, omeprazole, midazolam, rosiglitazone, metabolism, Drug Drug Interaction

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AZD3480 + cocktail

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo + cocktail

Intervention Type

Drug

Intervention Name(s)

AZD3480

Intervention Description

Capsule, oral, dose once daily, 7 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsule, oral, dose once daily, 7 days

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Cocktail mix which contains the following: CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin) single dose of mix

Primary Outcome Measure Information:

Title

PK variables

Time Frame

Frequent sampling occasions during the treatment periods

Secondary Outcome Measure Information:

Title

Safety variables (adverse events, blood pressure, pulse, safety lab)

Time Frame

During the whole treatment period

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans-Göran Hårdemark, MD

Organizational Affiliation

AstraZeneca R&D, Södertälje, Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Cyril Clarke, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Uppsala

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Drug Interaction Study Between AZD3480 and Cytochrome P450

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