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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.
March 17, 2009
March 18, 2009
May 14, 2012
April 2009
May 2009   (Final data collection date for primary outcome measure)
Pharmacokinetics (plasma blood concentrations) [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00864487 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib
A Study to Examine the Potential Effect of Rifampin on the Pharmacokinetics of Neratinib When Administered Concomitantly to Healthy Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Subjects
Drug: Neratinib
HKI-272
  • Experimental: 1
    Neratinib alone
    Intervention: Drug: Neratinib
  • Experimental: 2
    Neratinib plus rifampin
    Intervention: Drug: Neratinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2009
May 2009   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Healthy men or women (of non childbearing potential)
  • Ages 18 to 50 years old.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00864487
3144A1-1110
No
Not Provided
Not Provided
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Study Director: Puma Biotechnology
Puma Biotechnology, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP