Bioavailability Study of Bosutinib in Healthy Subjects (QBR115753)

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, RANDOMIZED, 2-PERIOD CROSSOVER STUDY TO EVALUATE ABSOLUTE BIOAVAILABILITY OF BOSUTINIB IN HEALTHY SUBJECTS

• IRAS ID

  158950

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2014-001405-40

• Clinicaltrials.gov Identifier

  NCT02192294

• Research summary

  The sponsor, Pfizer, is developing the study drug, bosutinib, for the treatment of a type of cancer called Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML).

  The purpose of this study is to fully understand this drug and how it is taken up by the body. Pfizer is required to perform this study to compare the amount of bosutinib in the blood following an oral dose (by mouth), with the amount in the blood following an intravenous (within the vein) dose.

  The study will consist of 2 study periods involving approximately 14 healthy male and female subjects at a single-site Phase I clinical trial unit. Subjects will receive the following 2 treatments in a randomised order over the 2 study periods (1 treatment per study period separated by a minimum washout period of 14 days):
  Treatment A (Oral bosutinib): Commercial tablet formulation of bosutinib (5 tablets each of 100 milligrams [mg]) following a standard breakfast.

  Treatment B (Intravenous bosutinib): Intravenous solution of bosutinib (120 mg) given over a 1 hour period following a standard breakfast.

• REC name

  Wales REC 1

• REC reference

  14/WA/1019

• Date of REC Opinion

  9 Jul 2014

• REC opinion

  Further Information Favourable Opinion