Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib

• Sponsor: Puma Biotechnology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00864487
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 24.4

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether co-administration of rifampin with neratinib has an effect on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of neratinib.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Examine the Potential Effect of Rifampin on the Pharmacokinetics of Neratinib When Administered Concomitantly to Healthy Subjects
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Neratinib alone	Drug: Neratinib; HKI-272
Experimental: 2 Neratinib plus rifampin	Drug: Neratinib; HKI-272

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (plasma blood concentrations) [4 weeks]

Eligibility Criteria

Criteria

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

Inclusion criteria:

• Healthy men or women (of non childbearing potential)

• Ages 18 to 50 years old.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Miami	Florida	United States	33126

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: NCT00864487
• Other Study ID Numbers: 3144A1-1110
• First Posted: Mar 18, 2009
• Last Update Posted: May 14, 2012
• Last Verified: May 1, 2012

Study Results

No Results Posted as of May 14, 2012