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

• ClinicalTrials.gov Identifier: NCT00990613
• Recruitment Status: Completed
• First Posted: October 7, 2009
• Last Update Posted: February 3, 2010
• Sponsor: Pfizer
• Collaborator: Medivation, Inc.
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: October 6, 2009
• First Posted Date: October 7, 2009
• Last Update Posted Date: February 3, 2010
• Study Start Date: October 2009
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 6, 2009): 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 [ Time Frame: 4 to 6 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 6, 2009): Safety endpoints include subjective symptoms/objective findings (including skin irritation), clinical safety laboratory assessments, 12 lead ECGs, and supine vital signs. [ Time Frame: 4 to 6 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin
• Official Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)

Condition

• Alzheimer's Disease
• Huntington's Disease

Intervention

• 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.

Study Arms

• Cohort 1
  Interventions:

  • Drug: Dimebon IR
  • Drug: Dimebon Transdermal
  • Drug: Dimebon Transdermal
• Cohort 2
  Interventions:

  • Drug: Dimebon IR
  • Drug: Dimebon Transdermal

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2010): 19
• Original Estimated Enrollment (submitted: October 6, 2009): 20
• Actual Study Completion Date: January 2010
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00990613
• Other Study ID Numbers: B1451038
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Medivation, Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2010