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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
  Purpose
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 Intervention Phase
Chronic Pain
Drug: AZD2066
Drug: Caffeine
Drug: Tolbutamide
Drug: Omeprazole Tablet, 20 mg
Drug: Midazolam Tablet, 7.5 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during ]

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: Frequent sampling occasions during ]

Enrollment: 15
Study Start Date: June 2009
Study Completion Date: September 2009
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930306

Locations
United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Biljana Lilja AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Simon Constable ICON Development Solutions, Manchester, UK
  More Information

Responsible Party: MSD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00930306     History of Changes
Other Study ID Numbers: D0475C00011
Study First Received: June 29, 2009
Last Updated: October 23, 2009

Keywords provided by AstraZeneca:
Chronic Pain
AZD2066

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Caffeine
Bupropion
Omeprazole
Midazolam
Metoprolol
Tolbutamide
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on March 29, 2017