Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757809
• Other study ID #: 3144A1-1116
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2008
• Last updated: May 10, 2012
• Start date: October 2008
• Est. completion date: October 2008

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy male and female (non-child bearing potential) subjects

• Ages 18-50.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• neratinib
HKI-272

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Puma Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of diarrhea		14 days	Yes