Drug Interaction study between AZD3480 and Cytochrome P450 - Cocktail
Study identifier:D3690C00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
metabolism
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3480, Placebo, Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)
Sex
Male
Actual Enrollment
18
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Nov 2007
Primary Completion Date: 01 Sept 2008
Study Completion Date: 01 Sept 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 |
Contacts
Investigators
Principal Investigator
Hans-Göran Hårdemark
AstraZeneca R&D, Södertälje, Sweden
