NCT00990613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 3, 2010

Status Verified

February 1, 2010

Enrollment Period

3 months

First QC Date

October 6, 2009

Last Update Submit

February 2, 2010

Conditions

Alzheimer's DiseaseHuntington's Disease

Keywords

percutaneous transcutaneous dimebon transdermal pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Cohort 1

OTHER
Drug: Dimebon IRDrug: Dimebon Transdermal

Cohort 2

OTHER
Drug: Dimebon IRDrug: Dimebon Transdermal

Interventions

Dimebon IRDRUG

A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.

Cohort 1
Dimebon TransdermalDRUG

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.

Cohort 1

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Location

Related Publications (1)

  • 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.

    PMID: 27072954DERIVED

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseHuntington Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBasal Ganglia DiseasesChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 7, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 3, 2010

Record last verified: 2010-02

Locations

US(1)