A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
Phase 1
Completed
- Conditions
- Huntington DiseaseAlzheimer Disease
- Interventions
- Registration Number
- NCT00788047
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Regimen B (Test) Dimebon + Dextromethorphan - Regimen A (Reference) Dextromethorphan -
- Primary Outcome Measures
Name Time Method Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone Day 12
- Secondary Outcome Measures
Name Time Method Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms) Day 15 Dextrorphan (the metabolite of dextromethorphan) exposure Day 12
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States