Status:
COMPLETED
A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Alzheimer's Disease
Huntington's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief Summary
To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00990613
Start Date
October 1 2009
End Date
January 1 2010
Last Update
February 3 2010
Active Locations (1)
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1
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007