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| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
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This study is to characterize the pharmacokinetics of single and multiple oral doses of Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The secondary objective of this study is to compare the pharmacokinetics, safety and tolerability of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single dose cohort-Japanese group | Experimental | Japanese healthy subjects |
|
| single dose cohort-Western group | Experimental | Western healthy subjects |
|
| multiple dose cohort-Japanese group | Experimental | Japanese healthy subjects |
|
| multiple dose cohort-Western group | Experimental | Western healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimebon | Drug | dose escalation of single oral doses of 5, 10 and 20 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| plasma drug concentrations | 72 hours post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be including physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring | 72 hours post last dose |
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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 | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Dimebon |
| Drug |
dose escalation of single oral doses of 5, 10 and 20 mg |
|
| Dimebon | Drug | 10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days |
|
| Dimebon | Drug | 10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days |
|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| 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 |
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| ID | Term |
|---|---|
| C010119 | latrepirdine |
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