NCT00366600

Brief Summary

Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2006

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

August 17, 2006

Last Update Submit

September 6, 2017

Conditions

Healthy

Keywords

Breast CancerHealthPharmacokineticshealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics; safety and tolerability; influence of food on the same.

Interventions

neratinibDRUG

HKI-272

Eligibility Criteria

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

You may qualify if:

  • Healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Kinetics

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

neratinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Puma

    Biotechnology

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

US(1)