Relative Bioavailability of Ponatinib 5mg Capsules
Research type
Research Study
Full title
Relative Bioavailability of Ponatinib 5mg Capsules Administered Orally in Healthy Participants.
IRAS ID
252662
Contact name
Daniel Jabbari
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2018-002335-14
Duration of Study in the UK
0 years, 2 months, 6 days
Research summary
In this study, we compare the blood concentration of a new formulation (capsule) of Ponatinib with approved formulation of it which is called Iclusig® (Ponatinib, INCB084344). 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 capsule formulation of this drug, Ponatinib (INCB084344) 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 INCB084344 is in the blood after taking the study drug as an intact capsule, or the contents of a capsule mixed with apple sauce or yogurt, compared to Iclusig® taken as 1 tablet or 1 intact capsule
Learn about the safety of Ponatinib INCB084344 capsules
Learn how subjects tolerate Ponatinib INCB084344 capsulesREC name
HSC REC B
REC reference
18/NI/0155
Date of REC Opinion
27 Sep 2018
REC opinion
Further Information Favourable Opinion