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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00864487
First received: March 17, 2009
Last updated: May 10, 2012
Last verified: May 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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
Other Name: Neratinib
Experimental: 2
Neratinib plus rifampin
Drug: Neratinib
HKI-272
Other Name: Neratinib

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy men or women (of non childbearing potential)
  • Ages 18 to 50 years old.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864487

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

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00864487     History of Changes
Other Study ID Numbers: 3144A1-1110
Study First Received: March 17, 2009
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014