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Completed

NCT Number: NCT00990613

A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin

To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.

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Key information

Conditions

Alzheimer's 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 Huntington Disease Huntington's Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Caucasian, male or females, 50 to 85 years inclusive.
  • Subjects must have adequate space available on each side of the upper or middle back that is free from excessive hair, broken or irritated skin, tattoos, scars, moles, acne, and sunburn.

Exclusion criteria

  • Evidence or history of any major medical or psychiatric illness or unstable medical condition within six months of Screening that may increase the risk associated with study participation.
  • Subjects with any central nervous system disease including Alzheimer's disease, Parkinson's disease, Huntington disease, or any form of dementia.
  • Subjects with any history of stroke, known cerebrovascular disease or subjects with any history of structural brain disease.
  • Any history of epilepsy, seizure disorder (i.e., including febrile seizures) or convulsion.
  • Subjects with any skin disorders that might prevent application of the dimebon solution including, but not limited to, any known sensitivity to adhesives.

Treatment and study plan

Dimebon IR

Drug

A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.

Dimebon Transdermal

Drug

A single, transdermal 5 mg dose of dimebon free base solution will be applied to the back over a 24 hour period. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.

Primary outcomes

  1. Pharmacokinetic endpoints include dimebon area under the curve from 0 to the last quantifiable concentration (AUClast) and dimebon area under the curve from 0 to infinity (AUCinf) as permitted by data

    Time frame: 4 to 6 days

Secondary outcomes

  1. Safety endpoints include subjective symptoms/objective findings (including skin irritation), clinical safety laboratory assessments, 12 lead ECGs, and supine vital signs.

    Time frame: 4 to 6 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Medivation, Inc.

Registry information

Official study title

A Phase 1, Fixed Sequence, Cross-Over Study To Investigate The Single Dose Pharmacokinetics Of A Dimebon (Latrepirdine) Transdermal Solution Relative To The Immediate Release Formulation In Older Adults

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2009
Registry last updated
Feb 3, 2010

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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