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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: neratinib

• Registration Number: NCT00550212
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2007-10-26
• Study First Posted: 2007-10-29
• Study Start: 2008-03
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Healthy male subjects, aged 18 to 50 years.

Exclusion Criteria

• Female subjects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	neratinib	240 mg

Primary Outcome Measures

Name	Time	Method
Mass balance, metabolic distribution, PK	10 days