AZD2066 Cocktail Study

October 23, 2009 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK variables
Time Frame: Frequent sampling occasions during
Frequent sampling occasions during

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Biljana Lilja, AstraZeneca R&D, Södertälje, Sweden
  • Principal Investigator: Simon Constable, ICON Development Solutions, Manchester, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 23, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0475C00011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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