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Trial record 36 of 55 for:    hki-272 OR neratinib

HKI-272 Ketoconazole Drug Interaction Study

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.
ClinicalTrials.gov Identifier: NCT00380328
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-administered.

Condition or disease Intervention/treatment Phase
Healthy Drug: neratinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, 2-period Crossover, Drug Interaction Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of HKI-272 Administered Orally to Healthy Subjects
Study Start Date : October 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions


Intervention Details:
  • Drug: neratinib
    HKI-272


Primary Outcome Measures :
  1. Pharmacokinetics; safety and tolerability


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

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): NCT00380328


Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
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Study Director: Puma Biotechnology

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Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00380328     History of Changes
Other Study ID Numbers: 3144A1-106
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by Puma Biotechnology, Inc.:
Pharmacokinetic
healthy subjects

Additional relevant MeSH terms:
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Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors