Alzheimer's Disease, Huntington's Disease
Conditions
Keywords
percutaneous transcutaneous dimebon transdermal pharmacokinetics
Brief summary
To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.
Interventions
DRUGDimebon IR
A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.
DRUGDimebon Transdermal
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.
Sponsors
Medivation, Inc.
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 4 to 6 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints include subjective symptoms/objective findings (including skin irritation), clinical safety laboratory assessments, 12 lead ECGs, and supine vital signs. | 4 to 6 days |
Countries
United States
Outcome results
None listed