AZD2066 Cocktail Study

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00930306

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

7.5

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: AZD2066 Drug: Caffeine Drug: Tolbutamide Drug: Omeprazole Tablet, 20 mg Drug: Midazolam Tablet, 7.5 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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 Start Date :

Jun 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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 12 doses, Given as capsule, 2 mg & 8 mg Drug: Caffeine 2 doses, Given as Tablet, 2x50 mg Other Names: Pharmapac/ProPlus® Drug: Tolbutamide 2 doses, Given as Tablet, half of 500 mg Other Names: Actavis /generic Drug: Omeprazole Tablet, 20 mg 2 doses, Given as Tablet, 20 mg Other Names: AstraZeneca/Losec® MUPS® Drug: Midazolam Tablet, 7.5 mg 2 doses, Given as Tablet, 7.5 mg Other Names: Roche/generic

Arm

Intervention/Treatment

Experimental: 1

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

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

Drug: Caffeine

2 doses, Given as Tablet, 2x50 mg

Other Names:

Pharmapac/ProPlus®

Drug: Tolbutamide

2 doses, Given as Tablet, half of 500 mg

Other Names:

Actavis /generic

Drug: Omeprazole Tablet, 20 mg

2 doses, Given as Tablet, 20 mg

Other Names:

AstraZeneca/Losec® MUPS®

Drug: Midazolam Tablet, 7.5 mg

2 doses, Given as Tablet, 7.5 mg

Other Names:

Roche/generic

Outcome Measures

Primary Outcome Measures

PK variables [Frequent sampling occasions during]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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