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
Completed · Phase 1
Conditions studied: Alzheimer's Disease, Huntington's Disease
In brief
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.
Key facts
- Study ID
- NCT00827034
- Run by
- Pfizer
- People needed
- 14
- Starts
- 2009-02-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2018-10-16
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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