Palatability Assessment of Ivosidenib in Healthy Adults (QSC201688)
Research type
Research Study
Full title
An Open-Label Palatability Assessment Study of Ivosidenib in Healthy Adult Subjects
IRAS ID
257857
Contact name
Nirav Patel
Contact email
Sponsor organisation
Agios Pharmaceuticals
Duration of Study in the UK
0 years, 0 months, 27 days
Research summary
The Sponsor is developing the test medicine, ivosidenib (AG-120), for the potential treatment of tumours, which is the abnormal growth of cells.
Two different tablet strengths of the test medicine (50 mg and 250 mg) have been developed for adults. As these tablets readily disintegrate in water, there is the opportunity for an easy-to-prepare dosage form for children.
The study will investigate the palatability (taste) of the 2 different dose strength tablets in a number of different vehicles e.g. water, apple juice, apple sauce and plain yogurt in order to determine what further work needs to be completed to develop a dosage form for children.
The study will consist of 1 study period involving up to 14 healthy male and female volunteers. Each volunteer will be asked to taste approximately 1 tablespoon of the test medicine dispersed in a vehicle which will be held in the mouth for 10 to 15 seconds before it is expectorated (spat out). Volunteers will then complete a taste questionnaire individually and privately. No test medicine is to be consumed. Volunteers will be asked to complete 8 taste tests during the study period. There will be a minimum washout of 20 min between each taste test and during this time volunteers will be allowed to cleanse their palates using tap water and unsalted crackers before any further tasting.
REC name
HSC REC A
REC reference
19/NI/0056
Date of REC Opinion
29 Mar 2019
REC opinion
Favourable Opinion