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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00932464
Recruitment Status : Withdrawn (Study withdrawn as it no longer is deemed necessary per project status.)
First Posted : July 3, 2009
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Neratinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Neratinib
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2 [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932464


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

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00932464     History of Changes
Other Study ID Numbers: 3144A2-1112
B1891007
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012