Trial record 18 of 21 for:
Dimebon Alzheimer's
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
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00824590
First received: January 12, 2009
Last updated: December 29, 2009
Last verified: December 2009
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Purpose
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 |
|---|---|---|
|
Alzheimer's Disease Huntington's Disease |
Drug: Dimebon |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
chorea-acanthocytosis
Huntington disease
McLeod neuroacanthocytosis syndrome
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Plasma drug concentrations [ Time Frame: 96 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety assessment including physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring. [ Time Frame: 96 ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Severe renal impairment group
Subjects with severe renal impairment defined by creatinine clearance of less than 30 mL/min but not yet on dialysis
|
Drug: Dimebon
a single oral dose of 20 mg Dimebon
|
|
Experimental: normal renal function
Subjects with normal renal function defined by creatinine clearance of greater than 80 mL/min and demographically comparable to subjects with impaired renal function
|
Drug: Dimebon
a single oral dose of 20 mg Dimebon
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male and/or female subjects between the ages of 18 and 75 years, inclusive
- For severe renal impairment group, subjects with creatinine clearance of less than 30 mL/min, but not yet on dialysis and in good general health commensurate with the population with chronic renal disease; however, subjects with type 1 and 2 diabetes that are reasonably controlled and who do not have a predisposition to severe hypoglycemia can both be included.
- For normal renal function group, healthy subjects with creatinine clearance of greater than 80mL/min and demographically comparable to subjects with impaired renal function
Exclusion Criteria:
- Pregnant or nursing women; women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to the first dose of study medication.
- 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 ≤ 2 grams/day is permitted.
- For renal impairment group, a known history of clinically significant coronary heart disease, cerebrovascular disease or peripheral vascular disease and/or an event/intervention during the past 6 months. Systemic therapy with CYP3A or CYP2D6 inhibitors within 7 days or 5 halflives (whichever is longer) prior to the first dose of trial medication.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824590
Locations
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33169 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| St. Paul, Minnesota, United States, 55114 | |
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00824590 History of Changes |
| Other Study ID Numbers: | B1451019 |
| Study First Received: | January 12, 2009 |
| Last Updated: | December 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Dimebon renal impairment pharmacokinetics |
Additional relevant MeSH terms:
|
Alzheimer Disease Huntington Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Basal Ganglia Diseases Chorea Dyskinesias Movement Disorders Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Cognition Disorders |
ClinicalTrials.gov processed this record on May 19, 2013