A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
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
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedMarch 9, 2009
March 1, 2009
2 months
November 7, 2008
March 5, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone
Day 12
Secondary Outcomes (2)
Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)
Day 15
Dextrorphan (the metabolite of dextromethorphan) exposure
Day 12
Study Arms (2)
Regimen A (Reference)
OTHERRegimen B (Test)
EXPERIMENTALInterventions
Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12
Eligibility Criteria
You may qualify if:
- Healthy adult subjects.
- Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Medivation, Inc.collaborator
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 7, 2008
First Posted
November 10, 2008
Study Start
November 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
March 9, 2009
Record last verified: 2009-03