Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Alzheimer's Disease
Huntington's Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 des...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00827034
Start Date
February 1 2009
End Date
April 1 2009
Last Update
October 16 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511