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NCT00932464 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00932464
Other study ID # 3144A2-1112
Secondary ID B1891007
Status Withdrawn
Phase Phase 1
First received July 1, 2009
Last updated May 10, 2012
Start date August 2012
Est. completion date August 2012

Study information
Verified date May 2012
Source Puma Biotechnology, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Neratinib
240-mg oral tablet; single dose under fasted conditions
• Neratinib
240-mg oral tablet; single dose with high-fat breakfast

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Puma Biotechnology, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2 6 weeks No
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