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

Puma Biotechnology

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00864487

3144A1-1110

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Healthy men or women (of non childbearing potential)
• Ages 18 to 50 years old.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

Neratinib alone

Treatment:

Drug: Neratinib

2

Experimental group

Description:

Neratinib plus rifampin

Treatment:

Drug: Neratinib