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AZD2066 Cocktail Study

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: AZD2066 (Drug); Caffeine (Drug); Tolbutamide (Drug); Omeprazole Tablet, 20 mg (Drug); Midazolam Tablet, 7.5 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Biljana Lilja, Study Director, Affiliation: AstraZeneca R&D, Södertälje, Sweden
Simon Constable, Principal Investigator, Affiliation: ICON Development Solutions, Manchester, UK


The aims of this study are to examine the effect of repeated doses of AZD2066 and of caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood concentrations of each other

Clinical Details

Official title: A Phase I, Open Label, Multi Centre Study in Healthy Volunteers to Estimate the Effect of Multiple Doses of AZD2066 on the Activity of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 by Administering a Cocktail of Caffeine, Bupropion, Tolbutamide, Omeprazole, Metoprolol and Midazolam

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: PK variables

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


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- Provision of informed consent prior to any study-specific procedures

- Healthy volunteers with BMI between 18 and 30 kg/m2

- Medical and surgical history and physical examination without any clinically

significant findings

- Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion Criteria:

- History of previous or ongoing psychiatric disease/condition including psychosis,

affective disorder, anxiety disorder, personality disorder or other significant psychiatric disorders or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator

- Clinically significant illness as judged by the Investigator, within four weeks

before the first administration of investigational product.

- Female subjects who have a positive pregnancy test or who are pregnant or


Locations and Contacts

Research Site, London, United Kingdom

Research Site, Manchester, United Kingdom

Additional Information

Starting date: June 2009
Last updated: October 23, 2009

Page last updated: August 23, 2015

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