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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00788047
Date of registration: 07/11/2008
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
Scientific 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
Date of first enrolment: November 2008
Target sample size: 14
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science  
Phase:  Phase 1
Countries of recruitment
United States
Name:     Pfizer Call Center
Affiliation:  Pfizer
Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Alzheimer Disease
Huntington Disease
Drug: Dextromethorphan
Drug: Dimebon + Dextromethorphan
Primary Outcome(s)
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone [Time Frame: Day 12]
Secondary Outcome(s)
Dextrorphan (the metabolite of dextromethorphan) exposure [Time Frame: Day 12]
Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms) [Time Frame: Day 15]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Medivation, Inc.
Ethics review
Results available:
Date Posted:
Date Completed:
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