Back to resultsA Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
Primary Purpose
Huntington Disease, Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan
Dimebon + Dextromethorphan
Sponsored by
About this trial
This is an interventional basic science trial for Huntington Disease
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Regimen A (Reference)
Regimen B (Test)
Arm Description
Outcomes
Primary Outcome Measures
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone
Secondary Outcome Measures
Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)
Dextrorphan (the metabolite of dextromethorphan) exposure
Full Information
NCT ID
NCT00788047
First Posted
November 7, 2008
Last Updated
March 5, 2009
Sponsor
Pfizer
Collaborators
Medivation, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00788047
Brief Title
A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
Medivation, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease, Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regimen A (Reference)
Arm Type
Other
Arm Title
Regimen B (Test)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
Dextromethorphan HCl 30 syrup single dose
Intervention Type
Drug
Intervention Name(s)
Dimebon + Dextromethorphan
Intervention Description
Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12
Primary Outcome Measure Information:
Title
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone
Time Frame
Day 12
Secondary Outcome Measure Information:
Title
Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)
Time Frame
Day 15
Title
Dextrorphan (the metabolite of dextromethorphan) exposure
Time Frame
Day 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1451022&StudyName=A%20Phase%201%20Study%20To%20Evaluate%20The%20Effect%20Of%20Dimebon%20On%20The%20Pharmacokinetics%20Of%20Dextromethorphan
Description
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Learn more about this trial
A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
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