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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757809

Enrollment

Registered

2008-09-23

Start date

2008-10-31

Completion date

2008-10-31

Last updated

2012-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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

Interventions

DRUGneratinib

HKI-272

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Occurence of diarrhea	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026