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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: Neratinib

• Registration Number: NCT00932464
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14
• Study Start: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Neratinib	Neratinib Fed
1	Neratinib	Neratinib Fasted

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2	6 weeks