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

Puma Biotechnology

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Digoxin; Drug: Neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860223

3144A1-1119

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Healthy men and women of non-childbearing potential, age 18-50

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

1

Experimental group

Description:

Digoxin alone

Treatment:

Drug: Digoxin

2

Experimental group

Description:

Digoxin plus neratinib

Treatment:

Drug: Digoxin

Drug: Neratinib