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
Summary
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
breast-feeding
Locations and Contacts
Research Site, London, United Kingdom
Research Site, Manchester, United Kingdom
Additional Information
Starting date: June 2009
Last updated: October 23, 2009
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