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

An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of The 240 mg Formulation Of Neratinib In Healthy Subjects

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00932464

Enrollment

Registered

2009-07-03

Start date

2012-08-31

Completion date

2012-08-31

Last updated

2012-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGNeratinib

240-mg oral tablet; single dose under fasted conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2	6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026