Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

• Sponsor: Puma Biotechnology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00814060
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Duration (Months): 1.9
• Patients Per Site Per Month: 12.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: neratinib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Dose Bioavailability Study of 2 New Tablet Formulations of Neratinib Compared With a Reference Capsule in Healthy Adult Subjects
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 40-mg tablet	Drug: neratinib; HKI-272
Experimental: 2 240-mg tablet	Drug: neratinib; HKI-272
Experimental: 3 80-mg capsule	Drug: neratinib; HKI-272

Outcome Measures

Primary Outcome Measures

1. Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272 [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Healthy male and female subjects, ages 18-50.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tacoma	Washington	United States	98418

Sponsors and Collaborators

• Puma Biotechnology, Inc.

Investigators

• Study Director: Puma, Biotechnology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Puma Biotechnology, Inc.
• ClinicalTrials.gov Identifier: NCT00814060
• Other Study ID Numbers: 3144A1-1117
• First Posted: Dec 23, 2008
• Last Update Posted: May 14, 2012
• Last Verified: May 1, 2012

Study Results

No Results Posted as of May 14, 2012