Cocktail: Drug Interaction Study Between AZD3480 and Cytochrome P450

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00692510

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Alzheimer's Disease	Drug: AZD3480 Drug: Placebo Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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 Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AZD3480 + cocktail	Drug: AZD3480 Capsule, oral, dose once daily, 7 days 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
Placebo Comparator: 2 Placebo + cocktail	Drug: Placebo Capsule, oral, dose once daily, 7 days 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

Arm

Intervention/Treatment

Experimental: 1

AZD3480 + cocktail

Drug: AZD3480

Capsule, oral, dose once daily, 7 days

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

Placebo Comparator: 2

Placebo + cocktail

Drug: Placebo

Capsule, oral, dose once daily, 7 days

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

Outcome Measures

Primary Outcome Measures

PK variables [Frequent sampling occasions during the treatment periods]

Secondary Outcome Measures

Safety variables (adverse events, blood pressure, pulse, safety lab) [During the whole treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Uppsala		Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Hans-Göran Hårdemark, MD, AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Cyril Clarke, MD, ICON Development Solutions Manchester, Manchester Science Park, Manchester, UK