Drug Interaction Study Between AZD3480 and Cytochrome P450

Alzheimer's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692510
• Other study ID #: D3690C00016
• Secondary ID: EudraCt nr 2007-
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2008
• Last updated: November 25, 2008
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: November 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Metabolism

Intervention

Drug:
• AZD3480
Capsule, oral, dose once daily, 7 days
• Placebo
Capsule, oral, dose once daily, 7 days
• 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

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during the treatment periods	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment period	Yes