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

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.
 
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

Tracking Information
First Submitted Date  ICMJE November 7, 2008
First Posted Date  ICMJE November 10, 2008
Last Update Posted Date March 9, 2009
Study Start Date  ICMJE November 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2009)		 Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone [ Time Frame: Day 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2008)		 Detromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone [ Time Frame: Day 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
  • Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms) [ Time Frame: Day 15 ]
  • Dextrorphan (the metabolite of dextromethorphan) exposure [ Time Frame: Day 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
  • Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electorcardiograms) [ Time Frame: Day 15 ]
  • Dextorphan (the metabolite of dextromethorphan) exposure [ Time Frame: Day 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Huntington Disease
  • Alzheimer Disease
Intervention  ICMJE
  • Drug: Dextromethorphan
    Dextromethorphan HCl 30 syrup single dose
  • 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
Study Arms  ICMJE
  • Regimen A (Reference)
    Intervention: Drug: Dextromethorphan
  • Experimental: Regimen B (Test)
    Intervention: Drug: Dimebon + Dextromethorphan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2008)		 14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00788047
Other Study ID Numbers  ICMJE B1451022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP