Evaluation of Taste Profile of Delafloxacin Formulations (QSC300199)
Research type
Research Study
Full title
A Single-Part, Randomised, Single-Blind Study Designed to Evaluate the Taste Profile of Delafloxacin Drug-in-Bottle Formulations in Healthy Subjects
IRAS ID
324222
Contact name
Nand Singh
Contact email
Sponsor organisation
Melinta Therapeutics, LLC
Duration of Study in the UK
0 years, 1 months, 6 days
Research summary
The active ingredient of the test product is approved for use in the USA as an intravenous infusion or oral tablet for the treatment of bacterial skin and skin structure infections. The Sponsor is now looking to develop an oral liquid formulation (recipe) for children aged 2 months to less than 18 years.\n\nThe taste of the test product is currently unknown, therefore the study will look at taste preference of the test product with various flavours and sweeteners. The study will evaluate overall acceptability of oral suspension formulations of the test product, and provide further information of the taste profile of each oral suspension formulation of the test product by assessing additional taste profile attributes.\n\nIt is planned to enrol up to 12 healthy male and non-pregnant, non-lactating female volunteers. Volunteers will receive 5 mL of the test product and keep it in their mouths for approximately 30 seconds before it is spat out. Volunteers will then complete a taste questionnaire individually and privately after each taste test. No test product is to be ingested/consumed.\n\nThere will be a minimum washout of 20 minutes between each taste assessment. During this time, volunteers will cleanse their palates using tap water and unsalted/very mildly salted crackers before further tasting. Volunteers will complete a total of 8 taste assessments on Day 1. \n\nVolunteers will be discharged on Day 2, 1 day after taste tests. A follow-up phone call will take place 3-7 days post final taste assessment for all volunteers, to ensure the continued wellbeing of volunteers. Volunteers are expected to be involved in this study for approximately 5 weeks from screening to the follow-up call.\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0230
Date of REC Opinion
24 Apr 2023
REC opinion
Further Information Favourable Opinion