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

May 10, 2012 updated by: Puma Biotechnology, Inc.

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Neratinib Fasted
Drug: Neratinib
240-mg oral tablet; single dose under fasted conditions
Other Names:
  • HKI-272
Drug: Neratinib
240-mg oral tablet; single dose with high-fat breakfast
Other Names:
  • HKI-272
Experimental: 2
Neratinib Fed
Drug: Neratinib
240-mg oral tablet; single dose under fasted conditions
Other Names:
  • HKI-272
Drug: Neratinib
240-mg oral tablet; single dose with high-fat breakfast
Other Names:
  • HKI-272

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puma Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2012

Last Update Submitted That Met QC Criteria

May 10, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 3144A2-1112
  • B1891007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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