A Taste Assessment for CRN04777 Paediatric Oral Solution Formulations
Research type
Research Study
Full title
A Randomised, Single-Blind, 8-Way Crossover Study to Evaluate the Taste Attributes and Overall Acceptability of CRN04777 Paediatric Oral Solution Formulations in Healthy Subjects
IRAS ID
301705
Contact name
Chris Ferrara-Cook
Contact email
Sponsor organisation
Crinetics Pharmaceuticals, Inc.
Duration of Study in the UK
0 years, 0 months, 28 days
Research summary
Research Summary\nThe Sponsor is developing the test product, CRN04777, for the potential treatment of Congenital hyperinsulinism (HI), which is the most common cause of recurring hypoglycaemia in infants and children. Hypoglycaemia means low blood sugar and occurs when blood sugar levels drop too low. \n\nThere are treatments, such as specialised therapy and surgery, to help symptoms of hypoglycaemia, but there is currently no cure. The sponsor is developing the test product CRN04777 as another possible treatment for Congenital hyperinsulinism (HI).\n \nThe aim of this study is to evaluate the taste of several recipes of CRN04777 (the test products). These test products will have different flavours and volunteers will be asked to fill out a questionnaire based on how they taste.\n\nThis is a single-part, randomised study involving 12 healthy male and female volunteers of non-childbearing potential, aged 18 - 65.\n\nVolunteers will attend the clinical unit on one occasion to taste 8 test products. Each volunteer will be given the test product which they will hold in their mouth for approximately 30 seconds before it is expectorated (spat out). After each test product has been tasted, volunteers will then 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 and during this time volunteers will cleanse their palates using mineral water and unsalted crackers.\n\nVolunteers will be discharged the day after the taste tests. Volunteers will have a follow-up phone call 3 to 5 days later to ensure their continued wellbeing.\n\n\n
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0220
Date of REC Opinion
7 Oct 2021
REC opinion
Further Information Favourable Opinion