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

This study has been withdrawn prior to enrollment.

(Study withdrawn as it no longer is deemed necessary per project status.)

Sponsor:

Information provided by (Responsible Party):

Puma Biotechnology, Inc.

ClinicalTrials.gov Identifier:

NCT00932464

First received: July 1, 2009

Last updated: May 10, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 1, 2009

Last Updated Date

May 10, 2012

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00932464 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Neratinib
240-mg oral tablet; single dose under fasted conditions

Other Name: HKI-272
Drug: Neratinib
240-mg oral tablet; single dose with high-fat breakfast

Other Name: HKI-272

Study Arm (s)

Experimental: 1
Neratinib Fasted

Intervention: Drug: Neratinib
Experimental: 2
Neratinib Fed

Intervention: Drug: Neratinib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00932464

Other Study ID Numbers ^ICMJE

3144A2-1112, B1891007

Has Data Monitoring Committee

Responsible Party

Puma Biotechnology, Inc.

Study Sponsor ^ICMJE

Puma Biotechnology, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Puma

Biotechnology

Information Provided By

Puma Biotechnology, Inc.

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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