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Sponsors and Collaborators: |
Pfizer Medivation, Inc. |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00824590 |
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.
Condition | Intervention | Phase |
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Alzheimer's Disease Huntington's Disease |
Drug: Dimebon |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal Function |
Estimated Enrollment: | 20 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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
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Drug: Dimebon
a single oral dose of 20 mg Dimebon
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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
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Drug: Dimebon
a single oral dose of 20 mg Dimebon
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
For normal renal function group, use of prescription or non-prescription drugs, vitamins, or dietary supplements within 7 days of 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Acetaminophen at doses of
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Florida | |
Pfizer Investigational Site | Recruiting |
Miami, Florida, United States, 33169 | |
United States, Minnesota | |
Pfizer Investigational Site | Not yet recruiting |
St. Paul, Minnesota, United States, 55114 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | B1451019 |
Study First Received: | January 12, 2009 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00824590 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dimebon, renal impairment, pharmacokinetics |
Ganglion Cysts Alzheimer Disease Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Cognition Disorders Chorea |
Heredodegenerative Disorders, Nervous System Delirium, Dementia, Amnestic, Cognitive Disorders Genetic Diseases, Inborn Movement Disorders Mental Disorders Dementia Huntington Disease Delirium |
Alzheimer Disease Nervous System Diseases Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Cognition Disorders Chorea |
Heredodegenerative Disorders, Nervous System Delirium, Dementia, Amnestic, Cognitive Disorders Genetic Diseases, Inborn Movement Disorders Mental Disorders Dementia Tauopathies Huntington Disease |