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

March 5, 2009 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Regimen A (Reference)
Drug: Dextromethorphan
Dextromethorphan HCl 30 syrup single dose
EXPERIMENTAL: Regimen B (Test)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone
Time Frame: Day 12
Day 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)
Time Frame: Day 15
Day 15
Dextrorphan (the metabolite of dextromethorphan) exposure
Time Frame: Day 12
Day 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Medivation, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (ESTIMATE)

November 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 5, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1451022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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