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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00860223 |
The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin.
Condition | Intervention | Phase |
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Healthy |
Drug: Digoxin Drug: Neratinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Nonrandomized, Crossover Study to Evaluate the Potential Effect of Multiple Doses of Neratinib on the Pharmacokinetics of a Single Dose of Digoxin When Administered Orally to Healthy Adult Subjects |
Estimated Enrollment: | 24 |
Study Start Date: | April 2009 |
Study Completion Date: | April 2009 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Digoxin alone
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Drug: Digoxin |
2: Experimental
Digoxin plus neratinib
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Drug: Digoxin Drug: Neratinib |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3144A1-1119 |
Study First Received: | March 11, 2009 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00860223 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Healthy Subjects |
Digoxin Anti-Arrhythmia Agents Cardiovascular Agents Healthy |
Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Therapeutic Uses Physiological Effects of Drugs Digoxin |
Enzyme Inhibitors Anti-Arrhythmia Agents Cardiovascular Agents Protective Agents Pharmacologic Actions |