Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib

Puma Biotechnology, Inc.

Overview

This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Healthy

Interventions

NeratinibDRUG

240-mg oral tablet; single dose under fasted conditions

NeratinibDRUG

240-mg oral tablet; single dose with high-fat breakfast

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and women of nonchildbearing potential, age 18 to 50 years. Exclusion Criteria: * Any previous or current clinically significant medical condition or disease.

Outcomes

Primary Outcomes

Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2

Time frame: 6 weeks

Data from ClinicalTrials.gov

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