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
NCT00824590
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Glendale, California
- New Haven, Connecticut
- Miami, Florida
- St. Paul, Minnesota
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: Dimebon
a single oral dose of 20 mg Dimebon | |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 20 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2009 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 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.
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00824590 | |||
Other Study ID Numbers ICMJE | B1451019 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Medivation, Inc. | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |