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| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
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This study is to compare the pharmacokinetics of Dimebon in subjects with severe renal impairment to subjects with normal renal function after oral administration of a single oral 20-mg dose of Dimebon. This study is also to assess the safety and tolerability of a single oral 20-mg dose of Dimebon in subjects with severe renal impairment and subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe renal impairment group | Experimental | Subjects with severe renal impairment defined by creatinine clearance of less than 30 mL/min but not yet on dialysis |
|
| normal renal function | Experimental | Subjects with normal renal function defined by creatinine clearance of greater than 80 mL/min and demographically comparable to subjects with impaired renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimebon | Drug | a single oral dose of 20 mg Dimebon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma drug concentrations | 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment including physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring. | 96 |
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Inclusion Criteria:
Exclusion Criteria:
Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Acetaminophen at doses of ≤ 2 grams/day is permitted.
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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 | Miami | Florida | 33169 | United States | ||
| Pfizer Investigational Site |
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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 |
a single oral dose of 20 mg Dimebon |
|
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D006816 | Huntington Disease |
| D051437 | Renal Insufficiency |
| 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 |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C010119 | latrepirdine |
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