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
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/18/2018 |
| Start Date: | February 2009 |
| End Date: | April 2009 |
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.
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.
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.
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