Drug Interaction Study Between AZD3480 and Cytochrome P450

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00692510

Acronym

Cocktail

Enrollment

Registered

2008-06-06

Start date

2007-11-30

Completion date

2008-09-30

Last updated

2008-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Metabolism

Keywords

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

Brief summary

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

Interventions

DRUGAZD3480

Capsule, oral, dose once daily, 7 days

DRUGPlacebo

Capsule, oral, dose once daily, 7 days

DRUGCocktail 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
PK variables	Frequent sampling occasions during the treatment periods

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026