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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864487
First Posted: March 18, 2009
Last Update Posted: May 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
  Purpose
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 Intervention Phase
Healthy Subjects Drug: Neratinib Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • Pharmacokinetics (plasma blood concentrations) [ Time Frame: 4 weeks ]

Enrollment: 24
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Neratinib alone
Drug: Neratinib
HKI-272
Experimental: 2
Neratinib plus rifampin
Drug: Neratinib
HKI-272

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy men or women (of non childbearing potential)
  • Ages 18 to 50 years old.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864487


Locations
United States, Florida
Miami, Florida, United States, 33126
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00864487     History of Changes
Other Study ID Numbers: 3144A1-1110
First Submitted: March 17, 2009
First Posted: March 18, 2009
Last Update Posted: May 14, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers