NCT00932464

Brief Summary

This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
3.1 years until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

Same day

First QC Date

July 1, 2009

Last Update Submit

May 10, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Neratinib Fasted

Drug: Neratinib

2

EXPERIMENTAL

Neratinib Fed

Drug: Neratinib

Interventions

NeratinibDRUG

240-mg oral tablet; single dose under fasted conditions

Also known as: HKI-272
1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women of nonchildbearing potential, age 18 to 50 years.

You may not qualify if:

  • Any previous or current clinically significant medical condition or disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

neratinib

Study Officials

  • Puma

    Biotechnology

    STUDY DIRECTOR
0

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

July 1, 2009

First Posted

July 3, 2009

Study Start

August 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 14, 2012

Record last verified: 2012-05