NCT00757809

Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

A Blinded, Randomized, Multiple-Dose, Parallel Group Study to Characterize the Occurrence of Mild to Moderate Diarrhea After Administration of Neratinib Either 240-mg Once Daily or 120-mg Twice Daily for 14 Days to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	neratinib	HKI-272

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-09-23
• Last updated: 2012-05-14

Locations

2 sites across 1 country: United States