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

Phase 1

Completed

• Conditions: Alzheimer's Disease; Huntington's Disease
• Interventions: Drug: Dimebon IR; Drug: Dimebon Transdermal

• Registration Number: NCT00990613
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	Dimebon IR	-
Cohort 1	Dimebon Transdermal	-
Cohort 2	Dimebon IR	-
Cohort 2	Dimebon Transdermal	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Kalamazoo, Michigan, United States