Evaluation of the Taste Profile of Tenapanor as a Liquid (QSC204120)
Research type
Research Study
Full title
A Randomised, Single-blind Study to Evaluate the Taste Profile of Tenapanor Oral Solution Formulations with Various Sweeteners and Flavours
IRAS ID
318387
Contact name
Somasekhara Menakuru
Contact email
Sponsor organisation
Ardelyx, Inc.
Duration of Study in the UK
0 years, 1 months, 9 days
Research summary
Summary of Research\nThe active ingredient of the test product, tenapanor (also known as RDX5791 and AZD1722) was approved in USA for the treatment of irritable bowel syndrome with constipation (IBS-C; causing frequent bloating, abdominal pain and constipation) in adults in Sep 2019. The test product has previously been given as a tablet, and the sponsor is now looking to develop an oral liquid formulation (recipe) for children aged 2 to <18 years. \n\nThis study will look at taste preference of the test product with various flavours and sweeteners. The study will evaluate overall acceptability of oral solution formulations of the test product, and provide further information of the taste profile of each oral solution formulation of the test product by assessing additional taste profile attributes. \n\nIt is planned to enrol 14 healthy male and female volunteers. Volunteers will receive up to 7 test product taste assessments in one day. The test product will be tasted using the sip and spit technique for all taste tests. Volunteers will hold in their mouth for approximately 30 seconds before it is spat out. No test product is to be ingested/swallowed. After each tasting occasion, all volunteers will complete a taste questionnaire individually and privately.\n\nThere will be a minimum washout of 30 minutes between each taste assessment, during this time, volunteers will cleanse their palates using water and unsalted crackers before further testing.\n\nVolunteers will be discharged from the clinical unit approximately 24 hours post-first taste test. There will be a follow-up phone call 2 to 6 days after discharge to ensure the continued wellbeing of volunteers.\n\nSummary of Results\nGiven that this is a basic science study in healthy volunteers, no lay summary of results has been provided for reasons of commercial confidentiality .
REC name
Wales REC 2
REC reference
22/WA/0323
Date of REC Opinion
15 Nov 2022
REC opinion
Favourable Opinion