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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
  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
Endpoint Classification: Bio-availability Study
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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during ] [ Designated as safety issue: No ]

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

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
Genders Eligible for Study:   Both
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
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

No publications provided

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

Keywords provided by AstraZeneca:
Chronic Pain
AZD2066

Additional relevant MeSH terms:
Caffeine
Midazolam
Omeprazole
Tolbutamide
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
 Neurotransmitter Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on June 18, 2013