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

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NCT00788047

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Huntington Disease, Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy adult subjects.

- Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Huntington Disease, Alzheimer DiseaseA Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
NCT00788047
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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