AZD2066 Cocktail Study

Study identifier:D0475C00011

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Chronic Pain

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD2066, Caffeine, Tolbutamide, Omeprazole Tablet, 20 mg, Midazolam Tablet, 7.5 mg

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 01 Jun 2009

Primary Completion Date: -

Study Completion Date: 01 Sept 2009

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Arms	Assigned Interventions
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 Name: Pharmapac/ProPlus® Drug: Tolbutamide 2 doses, Given as Tablet, half of 500 mg Other Name: Actavis /generic Drug: Omeprazole Tablet, 20 mg 2 doses, Given as Tablet, 20 mg Other Name: AstraZeneca/Losec® MUPS® Drug: Midazolam Tablet, 7.5 mg 2 doses, Given as Tablet, 7.5 mg Other Name: Roche/generic

Arms

Assigned Interventions

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 Name: Pharmapac/ProPlus®

Drug: Tolbutamide
2 doses, Given as Tablet, half of 500 mg

Other Name: Actavis /generic

Drug: Omeprazole Tablet, 20 mg
2 doses, Given as Tablet, 20 mg

Other Name: AstraZeneca/Losec® MUPS®

Drug: Midazolam Tablet, 7.5 mg
2 doses, Given as Tablet, 7.5 mg

Other Name: Roche/generic

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1640&filename=CSR-D0475C00011.pdf
Download
CSR-D0475C00011.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

ICON Development Solutions, Manchester

0161 232 2802

paul.crossley@iconplc.com

Investigators

Principal Investigator

Biljana Lilja

AstraZeneca R&D, Södertälje, Sweden

AZD2066 Cocktail Study

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1640&filename=CSR-D0475C00011.pdf

CSR-D0475C00011.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator