Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: neratinib

• Registration Number: NCT00814060
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Study Start: 2009-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	neratinib	240-mg tablet
1	neratinib	40-mg tablet
3	neratinib	80-mg capsule

Primary Outcome Measures

Name	Time	Method
Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272	6 weeks