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

Puma Biotechnology, Inc.27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DigoxinDRUG

NeratinibDRUG

HKI-272

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Healthy men and women of non-childbearing potential, age 18-50

Locations (1)

Unnamed facility

Miami, Florida, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters: concentration of digoxin in blood and urine

Time frame: 5 days

Data from ClinicalTrials.gov

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