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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

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Miami, Florida, 33169 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease, Huntington's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00824590
Pfizer
Completed
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

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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 SummaryThis 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 DescriptionNot 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
  • Alzheimer's Disease
  • Huntington's Disease
Intervention  ICMJE Drug: Dimebon
a single oral dose of 20 mg Dimebon
Study Arms  ICMJE
  • 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
    Intervention: Drug: 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
    Intervention: Drug: Dimebon
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
 (submitted: January 16, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion DateOctober 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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