NCT00498745

Brief Summary

To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

First QC Date

July 9, 2007

Last Update Submit

May 10, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.

Interventions

neratinibDRUG

HKI-272

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Criteria: * Healthy male and female subjects aged 18 to 50 years. * Women of nonchildbearing potential (WONCBP)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

neratinib

Study Officials

  • Puma

    Biotechnology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

July 1, 2007

Study Completion

September 1, 2007

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

US(1)