A Taste Assessment for CRN04894 Paediatric Formulations (QSC300615)
Research type
Research Study
Full title
A Randomised, Single-Blind, 8-Way Crossover Study to Evaluate the Taste Attributes and Overall Acceptability of CRN04894 Paediatric Oral Solution Formulations in Healthy Subjects
IRAS ID
327277
Contact name
Somasekhara Menakuru
Contact email
Sponsor organisation
Crinetics Pharmaceuticals, Inc.
Duration of Study in the UK
0 years, 1 months, 4 days
Research summary
The Sponsor is developing the test product, CRN04894, to treat diseases of adrenocorticotropic hormone (ACTH) excess such as Cushing’s disease (CD), ectopic ACTH syndrome (EAS) and congenital adrenal hyperplasia (CAH).\n\nACTH is a hormone produced by the body (the pituitary gland) that plays a role in the body’s response to stress. The release of ACTH triggers your body to produce cortisol.\n\nIncreased ACTH levels can be caused by benign (non-cancerous) tumours in the pituitary gland. Increased ACTH levels elevate cortisol levels, which can cause weight gain, easy bruising, severe fatigue and high blood pressure.\n\nThe test product is expected to work by suppressing excessive ACTH levels and therefore reducing elevated levels of cortisol although this has not yet been evaluated in patient testing.\n\nThe aim of this study is to evaluate the taste of several recipes of CRN04894 (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 study will enrol 16 healthy male volunteers and female volunteers of non-childbearing potential, aged 18 - 55.\n\nEach 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 swallowed. 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/mildly salted crackers.\n\nVolunteers will complete 8 taste tests in a single day and 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. Volunteers are expected to be involved in this study for approximately 5 weeks from screening to the follow-up call.\n\nLay Summary of Results\n\nDue to the sensitivity and confidentiality of the data obtained, it is the Sponsor’s preference to not disclose a summary of results.\n Has the registry been updated to include summary results?: No\n If yes - please enter the URL to summary results:\n If no – why not?: This is a basic science study (non-CTIMP), therefore registration on a publicly accessible database is not a requirement.\n Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes\n If yes, describe or provide URLs to disseminated materials: This submission constitutes the required submission to the relevant regulatory authority, as per the dissemination plan. As this is a basic science study in healthy volunteers with commercially sensitive results, no further publications or presentations are currently planned.\n If pending, date when dissemination is expected:\n If no, explain why you didn’t follow it:\n Have participants been informed of the results of the study?: No\n If yes, describe and/or provide URLs to materials shared and how they were shared:\n If pending, date when feedback is expected:\n If no, explain why they haven’t: The findings of this basic science study are confidential due to commercial sensitivity. Therefore, it is not appropriate to share the results of this study with volunteers at this time.\n Have you enabled sharing of study data with others?: No\n If yes, describe or provide URLs to how it has been shared:\n If no, explain why sharing hasn’t been enabled: The findings of this basic science study have been shared with the Sponsor, Crinetics Pharmaceuticals, Inc., only. As these findings are confidential due to commercial sensitivity, it is not appropriate to share the results of this study with other researchers at this time.\n Have you enabled sharing of tissue samples and associated data with others?: No\n If yes, describe or provide a URL:\n If no, explain why: No tissue samples were taken in this basic science study, therefore this is not applicable.\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0517
Date of REC Opinion
28 Jun 2023
REC opinion
Favourable Opinion