NCT00864487

Brief Summary

The purpose of this study is to examine whether co-administration of rifampin with neratinib has an effect on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of neratinib.

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 Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

1 month

First QC Date

March 17, 2009

Last Update Submit

May 10, 2012

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (plasma blood concentrations)

    4 weeks

Study Arms (2)

1

EXPERIMENTAL

Neratinib alone

Drug: Neratinib

2

EXPERIMENTAL

Neratinib plus rifampin

Drug: Neratinib

Interventions

NeratinibDRUG

HKI-272

12

Eligibility Criteria

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

You may qualify if:

  • Healthy men or women (of non childbearing potential)
  • Ages 18 to 50 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, 33126, United States

Location

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

US(1)