NCT00814060

Brief Summary

This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

December 17, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

December 17, 2008

Last Update Submit

May 10, 2012

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272

    6 weeks

Study Arms (3)

1

EXPERIMENTAL

40-mg tablet

Drug: neratinib

2

EXPERIMENTAL

240-mg tablet

Drug: neratinib

3

EXPERIMENTAL

80-mg capsule

Drug: neratinib

Interventions

neratinibDRUG

HKI-272

123

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Healthy male and female subjects, ages 18-50.

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

Tacoma, Washington, 98418, 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
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 23, 2008

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

US(1)