Evaluation of the Taste Profile of PTC857 Oral Solution (QSC300049)
Research type
Research Study
Full title
A Single Part, Randomised, Single Blind Study Designed to Evaluate the Taste Profile of PTC857 Oral Solution
IRAS ID
325274
Contact name
Mandar Dali
Contact email
Sponsor organisation
PTC Therapeutics, Inc.
Duration of Study in the UK
0 years, 0 months, 29 days
Research summary
The Sponsor is developing the test medicine, PTC857, for the potential treatment of neurological diseases, including amyotrophic lateral sclerosis (ALS). This study is being conducted to assess the taste attributes and overall acceptability of the test product oral solution formulations. This one part study will look at the taste preference of the test product formulations with various flavours and with/without sweetener. \n\nIt is planned to enroll 14 healthy male and female volunteers. Volunteers will taste up to 5 test products in one day. The test products will be tasted using the sip and spit technique. Volunteers will hold the test product 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/ very mildly salted 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 3 to 7 days post-final taste test for any volunteers with ongoing side effects to ensure the continued wellbeing of the volunteers.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0084
Date of REC Opinion
15 May 2023
REC opinion
Further Information Favourable Opinion