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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Huntington Disease Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Regimen A (Reference)

Group Type OTHER

Dextromethorphan

Intervention Type DRUG

Dextromethorphan HCl 30 syrup single dose

Regimen B (Test)

Group Type EXPERIMENTAL

Dimebon + Dextromethorphan

Intervention Type DRUG

Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12

Interventions

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Dextromethorphan

Dextromethorphan HCl 30 syrup single dose

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes