Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

NCT ID: NCT00757809

Last Updated: 2012-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-10-31

Brief Summary

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Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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QD

Once daily

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

BID

Twice daily

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Interventions

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neratinib

HKI-272

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female (non-child bearing potential) subjects
* Ages 18-50.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Puma Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Puma

Role: STUDY_DIRECTOR

Biotechnology

Locations

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Austin, Texas, United States

Site Status

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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3144A1-1116

Identifier Type: -

Identifier Source: org_study_id

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