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Drug Interaction Study Between AZD3480 and Cytochrome P450 (Cocktail)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692510
First Posted: June 6, 2008
Last Update Posted: November 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.

Condition Intervention Phase
Metabolism Alzheimer's Disease Drug: AZD3480 Drug: Placebo Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Double Blind, Randomized, Two-Way Cross Over, Single- Centre Study in Healthy CYP2D6 Extensive Metabolizers and Poor Metabolizers to Investigate the Potential of AZD3480 to Inhibit Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 Activity

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]

Estimated Enrollment: 18
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD3480 + cocktail
Drug: AZD3480
Capsule, oral, dose once daily, 7 days
Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

Cocktail mix which contains the following:

CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin)

single dose of mix

Placebo Comparator: 2
Placebo + cocktail
Drug: Placebo
Capsule, oral, dose once daily, 7 days
Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

Cocktail mix which contains the following:

CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin)

single dose of mix


  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed written informed consent
  • Clinically normal physical findings and laboratory values

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma within three weeks before the first dose
  • History of clinically significant disease
  • Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692510


Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans-Göran Hårdemark, MD AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Cyril Clarke, MD ICON Development Solutions Manchester, Manchester Science Park, Manchester, UK
  More Information

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00692510     History of Changes
Other Study ID Numbers: D3690C00016
EudraCt nr 2007-002456-10
First Submitted: May 29, 2008
First Posted: June 6, 2008
Last Update Posted: November 26, 2008
Last Verified: November 2008

Keywords provided by AstraZeneca:
AZD3480
Cocktail
caffeine
bupropion
omeprazole
midazolam
rosiglitazone
metabolism
Drug Drug Interaction

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Midazolam
Caffeine
Bupropion
Omeprazole
Rosiglitazone
Bilirubin
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants