Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects - Full Text View

Sponsor:	Pfizer
Collaborator:	Medivation, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00831506

Purpose

This study has been designed to confirm, in healthy subjects, the lack of a clinically important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0.125 mg QD, a sensitive P-gp substrate recommended by FDA.

Condition	Intervention	Phase
Alzheimer Disease Huntington Disease	Drug: digoxin Drug: dimebon	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF-01913539) On The Safety, Tolerability, And Steady-State Pharmacokinetics Of Digoxin 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 Drug Reactions Huntington's Disease

Drug Information available for: Digoxin Dimebolin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

AUC24 and Cmin of digoxin on Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cmax, Tmax, Ae, and renal clearance of digoxin on Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Adverse event monitoring through Day 14 including physical/neurological examination findings [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
Clinical safety assessments through Day 14 including chemistry, hematology, and vital signs [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
12-lead ECGs through Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	February 2009
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A digoxin once daily (0.125 mg QD) plus placebo three times daily (TID), 8 hours apart for 14 days.	Drug: digoxin digoxin once daily (0.125 mg QD) plus placebo three times daily (TID), 8 hours apart for 14 days.
Experimental: B digoxin once daily (0.125 mg QD) plus Dimebon three times a day, 8 hours apart for 14 days (10 mg TID on Days 1-7 and 20 mg TID on Days 8-14).	Drug: digoxin digoxin once daily (0.125 mg QD) for 14 days. Drug: dimebon Dimebon three times a day, 8 hours apart for 14 days (10 mg TID on Days 1-7 and 20 mg TID on Days 8-14).

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 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).
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

A known history of hypersensitivity or previous intolerance to Dimebon or digoxin.
Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing) disease or clinical findings at screening.
Pregnant or nursing women; women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to the first dose of study medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831506

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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00831506 History of Changes
Other Study ID Numbers:	B1451021
Study First Received:	January 27, 2009
Last Updated:	June 9, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

digoxin dimebon drug-drug interaction study

Additional relevant MeSH terms:

Alzheimer Disease
Huntington Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Chorea
Dyskinesias
Movement Disorders

Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Digoxin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012