Evaluation of the Taste Profile of the Test Product (QSC204343)
Research type
Research Study
Full title
A Single-blind Study Designed to Evaluate the Taste Profile of Alectinib Drug in Bottle Formulations in Healthy Subjects
IRAS ID
288190
Contact name
Morihiko Hayashi
Contact email
Sponsor organisation
Chugai Pharmaceutical Co., Ltd.
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
Summary of Research
The Sponsor is developing a test product for the potential treatment of certain types of non-small cell lung cancer (NSCLC) in children. The test product is already available in capsule form, marketed in approximately 82 countries and can be prescribed by doctors to treat adult patients with NSCLC. The sponsor would now like to develop a formulation suitable for younger cancer patients.\n\nThe aim of this study is to evaluate the taste attributes of several recipes of the test product, the test product may be sweetened, unsweetened or with flavouring. Volunteers will be asked to fill out a questionnaire based on how they taste. \n\nThe study will enroll up to 12 healthy male and female volunteers of non-childbearing potential. Volunteers will attend the clinical unit on one occasion to taste 10 recipes of the test product. Each volunteer will be given the test product which they will hold in their mouth for 10 to 20 seconds 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 20 minutes between each taste test, during this time volunteers will be allowed to cleanse their palates using mineral water and unsalted crackers. \n\nVolunteers will be discharged the day after the taste tests and will have a follow-up phone call three to seven days after discharge to ensure their continued wellbeing. \n
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
20/NW/0387
Date of REC Opinion
19 Oct 2020
REC opinion
Further Information Favourable Opinion