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AZD2066 Cocktail Study

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00930306
Enrollment
15
Registered
2009-06-30
Start date
2009-06-30
Completion date
2009-09-30
Last updated
2009-10-27

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

Conditions

Chronic Pain

Keywords

Chronic Pain, AZD2066

Brief 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

Interventions

12 doses, Given as capsule, 2 mg & 8 mg

DRUGCaffeine

2 doses, Given as Tablet, 2x50 mg

2 doses, Given as Tablet, half of 500 mg

DRUGOmeprazole Tablet, 20 mg

2 doses, Given as Tablet, 20 mg

DRUGMidazolam Tablet, 7.5 mg

2 doses, Given as Tablet, 7.5 mg

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
PK variablesFrequent sampling occasions during

Secondary

MeasureTime frame
Safety variables (adverse events, blood pressure, pulse, safety lab)Frequent sampling occasions during

Countries

United Kingdom

Outcome results

None listed

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