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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Digoxin; Drug: Neratinib

• Registration Number: NCT00860223
• Lead Sponsor: Puma Biotechnology, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Study Start: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Digoxin	Digoxin alone
2	Digoxin	Digoxin plus neratinib
2	Neratinib	Digoxin plus neratinib

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters: concentration of digoxin in blood and urine	5 days