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This study has been withdrawn prior to enrollment.
(Study withdrawn as it no longer is deemed necessary per project status.)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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Neratinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Puma Biotechnology, Inc.:

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

Enrollment: 0
Study Start Date: August 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Neratinib Fasted
Drug: Neratinib
240-mg oral tablet; single dose under fasted conditions
Other Name: HKI-272
Experimental: 2
Neratinib Fed
Drug: Neratinib
240-mg oral tablet; single dose with high-fat breakfast
Other Name: HKI-272

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932464

Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00932464     History of Changes
Other Study ID Numbers: 3144A2-1112, B1891007
Study First Received: July 1, 2009
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014