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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This study has been withdrawn prior to enrollment.
(Study withdrawn as it no longer is deemed necessary per project status.)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
  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
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 May 21, 2013