Relative Bioavailability of Dasatinib in Healthy Males (QSC202385)
Research type
Research Study
Full title
A Single Part, Open-Label, Randomised, Three-Way Crossover Study Designed to Evaluate the Relative Bioavailability of Dasatinib Following Single Oral Administration of Dasatinib Prototype Tablets in Healthy Male Subjects
IRAS ID
264328
Contact name
Somasekhara Menakuru
Contact email
Sponsor organisation
Xspray Pharma AB
Eudract number
2019-001583-29
Duration of Study in the UK
0 years, 1 months, 4 days
Research summary
The Sponsor is developing a new formulation (recipe) of the test medicine dasatinib, for the potential treatment of specific types of chronic and acute leukaemia. \n\nThe study will try to identify how 2 new formulations of the test medicine are taken up by the body when given in the fasted state. One formulation will also be given with food. The safety and tolerability of the new formulations will also be investigated.\n\nThe study will consist of 3 study periods involving up to 18 healthy male volunteers. In each period volunteers will receive a single oral dose of 100 mg of the test medicine. Volunteers will be resident in the clinical for 2 days each period for blood samples to be taken and safety assessments performed. There will be at least 5 days between each dose of test medicine and volunteers will receive a follow-up phone call 5 to 7 days after the final dose to ensure their ongoing wellbeing. \n\n
REC name
HSC REC A
REC reference
19/NI/0125
Date of REC Opinion
2 Jul 2019
REC opinion
Favourable Opinion