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Trial record 1 of 1 for:    NCT00827034
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A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00827034
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 20, 2009
First Posted Date  ICMJE January 22, 2009
Last Update Posted Date October 16, 2018
Study Start Date  ICMJE February 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
  • Single dose pharmacokinetics (Cmax, AUCinf) of warfarin 25 mg with and without co-administration of steady-state Dimebon 20 mg TID in healthy adult subjects. [ Time Frame: 7+18 days ]
  • Single dose pharmacodynamics (INRmax, AUC-INR) of warfarin 25 mg with and without co-administration of steady-state Dimebon 20 mg TID in healthy adult subjects. [ Time Frame: 7+18 days ]
  • Safety and tolerability ( adverse event monitoring, physical examinations, vital signs, ECG's and clinical laboratory tests) of multiple doses of Dimebon 20 mg TID with a single dose of warfarin 25 mg in healthy adult subjects. [ Time Frame: 7+18 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
Brief Summary This study will evaluate the potential drug-drug interaction of Dimebon with the FDA-recommended CYP2C9 substrate warfarin in healthy subjects. Conformance with the guidance includes general study design using a randomized, open label, single-dose warfarin, steady-state Dimebon, 2-sequence, 2-treatment, 2-period crossover design with a minimum 7-day washout period between treatments.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer's Disease
  • Huntington's Disease
Intervention  ICMJE
  • Drug: Warfarin
    A: a single oral dose of warfarin 25 mg administered on Day 1 of the relevant dosing period, as tablets.
  • Drug: Dimebon
    B is oral doses of Dimebon 10 mg TID on Days 1 7 and Dimebon 20 mg TID on Days 8 17, with co administration of a single oral dose of warfarin 25 mg on Day 12 of the relevant dosing period, both as tablets
  • Drug: Warfarin
    B is oral doses of Dimebon 10 mg TID on Days 1 7 and Dimebon 20 mg TID on Days 8 17, with co administration of a single oral dose of warfarin 25 mg on Day 12 of the relevant dosing period, both as tablets
Study Arms  ICMJE
  • A
    A: Warfarin alone
    Intervention: Drug: Warfarin
  • B
    B: Dimebon and Warfarin co-administration
    Interventions:
    • Drug: Dimebon
    • Drug: Warfarin
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 21, 2009)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
  • Prothrombin time (PT)/INR, and partial thromboplastin time (PTT).
  • Plasma Protein C and Protein S activity (functional) within the normal reference range.

Exclusion Criteria:

  • A known sensitivity or previous intolerance to Dimebon or warfarin.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
  • Subjects receiving warfarin for treatment of active thromboembolic events (ie, pulmonary embolism, deep vein thrombosis), as well as subjects anticoagulated with prosthetic heart valves.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT00827034
Other Study ID Numbers  ICMJE B1451020
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
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP