NCT00860223

Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Digoxin
DRUG	Neratinib	HKI-272

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-03-12
• Last updated: 2012-05-14

Locations

1 site across 1 country: United States