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Completed

NCT Number: NCT00788047

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

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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Key information

Conditions

Huntington Disease Alzheimer Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dextromethorphan

Drug

Dextromethorphan HCl 30 syrup single dose

Dimebon + Dextromethorphan

Drug

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

Primary outcomes

  1. Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone

    Time frame: Day 12

Secondary outcomes

  1. Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)

    Time frame: Day 15

  2. Dextrorphan (the metabolite of dextromethorphan) exposure

    Time frame: Day 12

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Medivation, Inc.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 10, 2008
Registry last updated
Mar 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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