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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Neratinib

• Registration Number: NCT00864487
• Lead Sponsor: Puma Biotechnology, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Study Start: 2009-04
• Primary Completion: 2009-05
• Study Completion: 2009-05
• 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
1	Neratinib	Neratinib alone
2	Neratinib	Neratinib plus rifampin

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (plasma blood concentrations)	4 weeks