AZD2066 Cocktail Study

Study Overview
=================
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

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

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Drug: AZD2066
* Drug: Caffeine
* Drug: Tolbutamide
* Drug: Omeprazole Tablet, 20 mg
* Drug: Midazolam Tablet, 7.5 mg


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>12 AZD2066 Capsule, 2 mg & 8 mg 2 Caffeine Tablet, 2 x 50 mg 2 Tolbutamide Tablet, half of 500 mg 2 Omeprazole Tablet, 20 mg 2 Midazolam Tablet, 7.5 mg 2 Metoprolol Tablet, 100 mg 2 Bupropion Tablet, 150 mg | Drug: AZD2066<br>* 12 doses, Given as capsule, 2 mg & 8 mg<br>Drug: Caffeine<br>* 2 doses, Given as Tablet, 2x50 mg<br>* Other names: Pharmapac/ProPlus®;Drug: Tolbutamide<br>* 2 doses, Given as Tablet, half of 500 mg<br>* Other names: Actavis /generic;Drug: Omeprazole Tablet, 20 mg<br>* 2 doses, Given as Tablet, 20 mg<br>* Other names: AstraZeneca/Losec® MUPS®;Drug: Midazolam Tablet, 7.5 mg<br>* 2 doses, Given as Tablet, 7.5 mg<br>* Other names: Roche/generic;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | Frequent sampling occasions during | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Pain, AZD2066