NCT00380328

Brief Summary

To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-administered.

Trial Health

100
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 healthy

Timeline
Completed

Started Oct 2006

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

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

First QC Date

September 21, 2006

Last Update Submit

May 10, 2012

Conditions

Healthy

Keywords

Pharmacokinetichealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics; safety and tolerability

Interventions

neratinibDRUG

HKI-272

Eligibility Criteria

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

You may qualify if:

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 25, 2006

Study Start

October 1, 2006

Study Completion

November 1, 2006

Last Updated

May 14, 2012

Record last verified: 2012-05