AZD2066 Cocktail Study

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”

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

Intervention(s) in this Clinical Trial

• Drug: AZD2066
  • 12 doses, Given as capsule, 2 mg & 8 mg
• Drug: Caffeine
  • 2 doses, Given as Tablet, 2x50 mg
• Drug: Tolbutamide
  • 2 doses, Given as Tablet, half of 500 mg
• Drug: Omeprazole Tablet, 20 mg
  • 2 doses, Given as Tablet, 20 mg
• Drug: Midazolam Tablet, 7.5 mg
  • 2 doses, Given as Tablet, 7.5 mg

Arms, Groups and Cohorts in this Clinical Trial

• 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

Primary Measures

• PK variables
  • Time Frame: Frequent sampling occasions during
    Safety Issue?: No

Secondary Measures

• Safety variables (adverse events, blood pressure, pulse, safety lab)
  • Time Frame: Frequent sampling occasions during
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Biljana Lilja Study Director AstraZeneca R&D, Södertälje, Sweden  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930306

Study ID Number: D0475C00011

ClinicalTrials.gov Identifier: NCT00930306

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency