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 - Full Text View

Sponsors and Collaborators:	Pfizer Medivation, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00827034

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease Huntington's Disease	Drug: Warfarin Drug: Dimebon	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Alzheimer's Disease Blood Thinners Huntington's Disease Hurricanes

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium Dimebolin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	February 2009
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A A: Warfarin alone	Drug: Warfarin A: a single oral dose of warfarin 25 mg administered on Day 1 of the relevant dosing period, as tablets.
B B: Dimebon and Warfarin co-administration	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

Arms

Assigned Interventions

A

A: Warfarin alone

Drug: Warfarin

A: a single oral dose of warfarin 25 mg administered on Day 1 of the relevant dosing period, as tablets.

B

B: Dimebon and Warfarin co-administration

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827034

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Medivation, Inc.

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1451020
Study First Received:	January 20, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00827034 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Dimebon Warfarin Drug-Drug Interaction

Study placed in the following topic categories:

Anticoagulants
Ganglion Cysts
Alzheimer Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Warfarin
Healthy
Brain Diseases
Neurodegenerative Diseases
Dyskinesias

Cognition Disorders
Chorea
Heredodegenerative Disorders, Nervous System
Delirium, Dementia, Amnestic, Cognitive Disorders
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Dementia
Huntington Disease
Delirium

Additional relevant MeSH terms:

Anticoagulants
Hematologic Agents
Alzheimer Disease
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Warfarin
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Pharmacologic Actions

Cognition Disorders
Chorea
Heredodegenerative Disorders, Nervous System
Delirium, Dementia, Amnestic, Cognitive Disorders
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Therapeutic Uses
Dementia
Tauopathies
Huntington Disease

ClinicalTrials.gov processed this record on September 11, 2009