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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kalamazoo, Michigan, 49007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease, Huntington's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00990613
Pfizer
Completed
A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin

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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
To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
  • Alzheimer's Disease
  • Huntington's Disease
  • 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 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.
  • Cohort 1
    Interventions:
    • Drug: Dimebon IR
    • Drug: Dimebon Transdermal
    • Drug: Dimebon Transdermal
  • Cohort 2
    Interventions:
    • Drug: Dimebon IR
    • Drug: Dimebon Transdermal
Chew ML, Mordenti J, Yeoh T, Ranade G, Qiu R, Fang J, Liang Y, Corrigan B. Minimization of CYP2D6 Polymorphic Differences and Improved Bioavailability via Transdermal Administration: Latrepirdine Example. Pharm Res. 2016 Aug;33(8):1873-80. doi: 10.1007/s11095-016-1922-4. Epub 2016 Apr 12.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
January 2010
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00990613
B1451038
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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