Relative Bioavailability of Ponatinib MiniTab Capsules and Tablet

• Research type

  Research Study

• Full title

  Relative Bioavailability of Ponatinib Minitab Capsules and Tablet Administered Orally in Healthy Participants.

• IRAS ID

  265469

• Contact name

  Daniel Jabbari

• Contact email

  daniel.jabbari@celerion.com

• Sponsor organisation

  Incyte Corporation

• Eudract number

  2019-001163-73

• Duration of Study in the UK

  0 years, 2 months, 9 days

• Research summary

  In this study, we compare the blood concentration of a new formulation MiniTab(capsule) of Ponatinib with approved formulation of it which is called Iclusig® (Ponatinib). Iclusig® has been approved by Medicines and Health Care Regulatory Agency (MHRA) and is used for the treatment of some forms of adult Leukemia.

  The sponsoring company for this clinical trial, Incyte, has developed a new Minitab capsule formulation of this drug, Ponatinib that is intended to be used for children, it still has to be approved by the MHRA.

  The purposes of this study are to:
  Find out how much Ponatinib is in the blood after taking the study drug as an intact Minitab capsule, or the contents of a capsule mixed with apple sauce or yogurt, compared to Iclusig® taken as 1 tablet.

  Learn about the safety of Ponatinib MiniTab capsules
  Learn how subjects tolerate Ponatinib capsules

• REC name

  HSC REC B

• REC reference

  19/NI/0093

• Date of REC Opinion

  7 Jun 2019

• REC opinion

  Further Information Favourable Opinion