Taste and Mouthfeel Evaluation of an Oral Suspension (QSC204795)
Research type
Research Study
Full title
A Study to Evaluate the Taste and Mouthfeel of TAVT-45 (abiraterone acetate) Granules for Oral Suspension Reconstituted in Specified Volumes of Water and Fruit Juices
IRAS ID
289905
Contact name
Litza McKenzie
Contact email
Sponsor organisation
Tavanta Therapeutics
Duration of Study in the UK
0 years, 0 months, 28 days
Research summary
Summary of Research
The Sponsor is developing the test product, TAVT-45 (abiraterone acetate), for the potential treatment of certain types of prostate cancer. Abiraterone acetate is already available to be prescribed by doctors to treat patients with prostate cancer, marketed under the name Zytiga. Currently this is given as a large tablet which is difficult to swallow, thus the Sponsor would like to develop a new formulation (recipe) of the test product as an oral suspension (liquid mixed with undissolved powder), which would be easier for patients to swallow. \n\nThe study will try to evaluate the taste and mouthfeel of the test product when given with different amounts of water or fruit juices. It will also try to determine the most appropriate fruit juice and amount of fruit juice to use in clinical trials. Volunteers will be asked to fill out a questionnaire based on how the test product tastes. \n\nThe study will enroll up to 12 healthy male volunteers. Volunteers will enter the clinical unit on Day -1 (the day before taste testing) and will taste up to 13 recipes of the test product over up to two days. Each volunteer will be given the test product which they will hold in their mouth for approximately one minute before it is spat out. After each test product recipe, volunteers will complete a taste questionnaire individually and privately. No test product is to be ingested. There will be a minimum washout of 30 minutes between each taste test, during this time volunteers will cleanse their palates using mineral water and unsalted crackers. Volunteers will be discharged after completion of the taste tests on either Day 1 or Day 2 and will have a follow-up telephone call three to five days after discharge to ensure their continued wellbeing. \n
REC name
HSC REC B
REC reference
20/NI/0149
Date of REC Opinion
27 Nov 2020
REC opinion
Further Information Favourable Opinion