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

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ClinicalTrials.gov Identifier: NCT00831506
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : June 12, 2009
Medivation, Inc.
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer Disease Huntington Disease Drug: digoxin Drug: dimebon Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2009
Primary Completion Date : May 2009
Study Completion Date : May 2009

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. AUC24 and Cmin of digoxin on Day 14 [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Cmax, Tmax, Ae, and renal clearance of digoxin on Day 14 [ Time Frame: Day 14 ]
  2. Adverse event monitoring through Day 14 including physical/neurological examination findings [ Time Frame: Day 14 ]
  3. Clinical safety assessments through Day 14 including chemistry, hematology, and vital signs [ Time Frame: Day 14 ]
  4. 12-lead ECGs through Day 14 [ Time Frame: Day 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831506

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00831506     History of Changes
Other Study ID Numbers: B1451021
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by Pfizer:
digoxin dimebon drug-drug interaction study

Additional relevant MeSH terms:
Alzheimer Disease
Huntington Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs