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A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan

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ClinicalTrials.gov Identifier: NCT00788047
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : March 9, 2009
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer

Brief Summary:
This drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.

Condition or disease Intervention/treatment Phase
Huntington Disease Alzheimer Disease Drug: Dextromethorphan Drug: Dimebon + Dextromethorphan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects
Study Start Date : November 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009


Arm Intervention/treatment
Regimen A (Reference) Drug: Dextromethorphan
Dextromethorphan HCl 30 syrup single dose

Experimental: Regimen B (Test) Drug: Dimebon + Dextromethorphan
Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12




Primary Outcome Measures :
  1. Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone [ Time Frame: Day 12 ]

Secondary Outcome Measures :
  1. Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms) [ Time Frame: Day 15 ]
  2. Dextrorphan (the metabolite of dextromethorphan) exposure [ Time Frame: Day 12 ]


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

Inclusion Criteria:

  • Healthy adult subjects.
  • Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.

Exclusion Criteria:

  • Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects.
  • Pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the first dose of study medication.

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): NCT00788047


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00788047     History of Changes
Other Study ID Numbers: B1451022
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Alzheimer Disease
Huntington Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs