Trial record 20 of 21 for:
Dimebon Alzheimer's
Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00831506
First received: January 27, 2009
Last updated: June 9, 2009
Last verified: June 2009
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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 1 |
| 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
Huntington disease
McLeod neuroacanthocytosis syndrome
Drug Information available for:
Digoxin
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:
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 May 16, 2013