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AZD2066 Cocktail Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00930306
First received: June 29, 2009
Last updated: October 23, 2009
Last verified: October 2009
History of Changes

June 29, 2009
October 23, 2009
June 2009
Not Provided
PK variables [ Time Frame: Frequent sampling occasions during ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930306 on ClinicalTrials.gov Archive Site
Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: Frequent sampling occasions during ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Chronic Pain
  • 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
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
Interventions:
  • Drug: AZD2066
  • Drug: Caffeine
  • Drug: Tolbutamide
  • Drug: Omeprazole Tablet, 20 mg
  • Drug: Midazolam Tablet, 7.5 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2009
Not Provided

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00930306
D0475C00011
No
MSD, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Biljana Lilja AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Simon Constable ICON Development Solutions, Manchester, UK
AstraZeneca
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP