NCT00990613

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Alzheimer's Disease
• Huntington's Disease

Interventions

Type	Name	Description
DRUG	Dimebon IR	A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.
DRUG	Dimebon 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.
DRUG	Dimebon Transdermal	A single, to be determined dose of dimebon free base solution will be applied to the back over a 24 hour period. The dose level chosen will be determined based on the pharmacokinetic/safety profile of the 5 mg dose. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
DRUG	Dimebon IR	A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.
DRUG	Dimebon Transdermal	A single, to be determined dose of dimebon free base solution will be applied to the back over a 24 hour period. The dose level chosen will be determined based on the pharmacokinetic/safety profile of the 5 mg dose in Cohort 1. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-10-07
• Last updated: 2010-02-03

Locations

1 site across 1 country: United States