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
1 other identifier
interventional
50
1 country
2
Brief Summary
Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 23, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 14, 2012
May 1, 2012
Same day
September 19, 2008
May 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Occurence of diarrhea
14 days
Study Arms (2)
QD
EXPERIMENTALOnce daily
BID
EXPERIMENTALTwice daily
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female (non-child bearing potential) subjects
- Ages 18-50.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Austin, Texas, 78752, United States
Unknown Facility
Tacoma, Washington, 98418, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Puma
Biotechnology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 23, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 14, 2012
Record last verified: 2012-05