Safety, Tolerability and Uptake of XS003 and Food Effect (QBR114327)
Research type
Research Study
Full title
A Comparative, Proof of Concept Study, comprising of a Pilot Phase Bioavailability Study Part and a randomised, cross-over Food-effect Study Part of XS003 and Originator in Healthy Male Subjects
IRAS ID
139495
Contact name
Joanne Collier
Contact email
Sponsor organisation
XSpray
Eudract number
2013-004115-50
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the study drug, XS003, as a potential treatment for chronic myelogenous leukaemia (CML), a cancer of the white blood cells.
The purpose of the study is to investigate the safety, tolerability and bodily uptake of a new formulation of Nilotinib (XS003) compared to the reference drug Tasigna®.
The study will be divided into 2 parts. Part 1 will involve 4 study periods where 3 different dose levels of the study drug (dosed at 85-150mg) will be compared to the reference drug Tasigna®; dosed at 150mg). Part 1 will be carried out in 9 healthy male volunteers.
Part 2 will involve 2 study periods. In one of the treatment periods, subjects will be given the study drug (dosed at 85-150mg based on the results from Part 1) after a high fat breakfast. Part 2 will be carried out in 18 healthy male volunteers.
REC name
HSC REC A
REC reference
13/NI/0175
Date of REC Opinion
15 Nov 2013
REC opinion
Further Information Favourable Opinion