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Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

NCT ID: NCT00814060

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-03-31

Brief Summary

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This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

40-mg tablet

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

2

240-mg tablet

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

3

80-mg capsule

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 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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Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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3144A1-1117

Identifier Type: -

Identifier Source: org_study_id

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