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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
History of Changes
  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:

Drug Information available for: Rifampin
U.S. FDA Resources

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
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 May 23, 2013