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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

March 17, 2009
May 10, 2012
April 2009
May 2009   (final data collection date for primary outcome measure)
Pharmacokinetics (plasma blood concentrations) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Subjects
Drug: Neratinib
HKI-272
Other Name: Neratinib
  • 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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00864487
3144A1-1110
No
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