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Drug Interaction Study Between AZD3480 and Cytochrome P450 (Cocktail)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00692510
First received: May 29, 2008
Last updated: November 25, 2008
Last verified: November 2008
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

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

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 29, 2008
Last Updated: November 25, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Bilirubin
Caffeine
Midazolam
Bupropion
Omeprazole
Rosiglitazone
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on June 18, 2013