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Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects

NCT ID: NCT00550212

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

240 mg

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272, Single-dose capsule and solution

Interventions

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neratinib

HKI-272, Single-dose capsule and solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects, aged 18 to 50 years.

Exclusion Criteria

* Female subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

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

Other Identifiers

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3144A1-1108

Identifier Type: -

Identifier Source: org_study_id

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