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Absolute Bioavailability Of Bosutinib

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. Identifier: NCT02192294
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : October 31, 2014
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE July 14, 2014
First Posted Date  ICMJE July 16, 2014
Last Update Posted Date October 31, 2014
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
Area under the Concentration-Time Curve (AUC) [ Time Frame: 96 hours ]
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 96 hours ]
    Maximum Observed Plasma Concentration
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 96 hours ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 96 hours ]
    Time to Reach Maximum Observed Plasma Concentration
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 96 hours ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Systemic Clearance (CL) [ Time Frame: 96 hours ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.
  • Volume of Distribution at Steady State (Vss) [ Time Frame: 96 hours ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Absolute Bioavailability Of Bosutinib
Official Title  ICMJE An Open-label, Randomized, 2-period Crossover Study To Evaluate Absolute Bioavailability Of Bosutinib In Healthy Subjects
Brief Summary This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Oral Bosutinib
    a single dose of 500 mg oral bosutinib
  • Drug: Intravenous infusion of bosutinib
    a single dose of 120 mg of bosutinib intravenous infusion (1 hour)
Study Arms  ICMJE Experimental: Bosutinib
  • Drug: Oral Bosutinib
  • Drug: Intravenous infusion of bosutinib
Publications * Hsyu PH, Pignataro DS, Matschke K. Absolute Bioavailability of Bosutinib in Healthy Subjects From an Open-Label, Randomized, 2-Period Crossover Study. Clin Pharmacol Drug Dev. 2018 May;7(4):373-381. doi: 10.1002/cpdd.396. Epub 2017 Oct 23.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2014)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects (of non-childbearing potential).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, accept placement of indwelling catheter for infusion and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
  • A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02192294
Other Study ID Numbers  ICMJE B1871044
2014-001405-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date October 2014

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