NCT00550212

Brief Summary

The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1 healthy

Status
completed

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

October 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

1 month

First QC Date

October 25, 2007

Last Update Submit

May 10, 2012

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Mass balance, metabolic distribution, PK

    10 days

Study Arms (1)

1

EXPERIMENTAL

240 mg

Drug: neratinib

Interventions

neratinibDRUG

HKI-272, Single-dose capsule and solution

1

Eligibility Criteria

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

You may qualify if:

  • Healthy male subjects, aged 18 to 50 years.

You may not qualify if:

  • Female subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

neratinib

Study Officials

  • Puma

    Biotechnology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 29, 2007

Study Start

March 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 14, 2012

Record last verified: 2012-05