Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: neratinib

• Registration Number: NCT00757809
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Study Start: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy male and female (non-child bearing potential) subjects
• Ages 18-50.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BID	neratinib	Twice daily
QD	neratinib	Once daily

Primary Outcome Measures

Name	Time	Method
Occurence of diarrhea	14 days