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| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
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To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other |
| |
| Cohort 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimebon IR | Drug | A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Kalamazoo | Michigan | 49007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27072954 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Dimebon Transdermal | Drug | 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. |
|
| Dimebon Transdermal | Drug | 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. |
|
| Dimebon IR | Drug | A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered. |
|
| Dimebon Transdermal | Drug | 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. |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001480 | Basal Ganglia Diseases |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |