Evaluation of Taste Profile of BI 3000202 Oral Formulation (QSC301724)
Research type
Research Study
Full title
A randomised, single-blind, single-period human taste assessment study to characterise the palatability and the acceptability of BI 3000202 in healthy male subjects and healthy female subjects of non-childbearing potential
IRAS ID
340215
Contact name
Nand Singh
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Duration of Study in the UK
0 years, 0 months, 29 days
Research summary
The Sponsor is developing the test product, BI 3000202, for the potential treatment of systemic sclerosis (SSc), a type of scleroderma, and potentially other autoinflammatory diseases which are conditions that are caused by a dysfunction of the immune system. The study is being conducted to assess the taste attributes and overall acceptability of different oral formulations. This one part study will look at the taste preference of six test product formulations with various sweetener and favour combinations and concentrations, compared to two reference formulations.
It is planned to enroll 16 healthy male and female of non-child breading potential participants. Participants will taste up to 8 test products in one day. The test products will be tasted using the sip and spit technique. Participants will hold the test product in their mouth for approximately 30 seconds before it is spat out. No test products are to be ingested/swallowed. After each tasting occasion, all participants will complete a taste questionnaire individually and privately.
There will be a minimum washout of 30 minutes between each taste assessment, during this time participants will cleanse their palates using water and unsalted/mildly salted crackers before further testing.
Participants will be discharged from the clinical unit approximately 7 hours post-first taste test. There will be a follow-up phone call 2 to 6 days post discharge to ensure the continued wellbeing of the participants.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
24/NW/0110
Date of REC Opinion
12 Apr 2024
REC opinion
Unfavourable Opinion