Phase I Trial (QSC300553)
Research type
Research Study
Full title
A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension with Oral Delafloxacin Tablet Reference in Healthy Subjects
IRAS ID
1009679
Contact name
Mike Snyder
Contact email
Sponsor organisation
Melinta Subsidiary Corp.
ISRCTN Number
ISRCTN10736175
Research summary
Delafloxacin (the test medicine) is an approved antibiotic for the treatment of adults with acute bacterial skin and skin structure infections and community acquired bacterial pneumonia, marketed in multiple countries, including in the US as Baxdela®, and in the EU. The test medicine is currently marketed as an oral tablet or intravenous (into the vein) form, and the Sponsor are looking to develop a liquid recipe (formulation) of the test medicine which can be taken by paediatric patients aged 2 months to less than 18 years.\n \nIn this study, up to 16 healthy male and female volunteers will receive up to 3 doses of the oral liquid formulation of the test medicine, and 1 dose of the marketed Baxdela® tablet. The blood levels of the different forms of the test medicine will be compared to see if the liquid formulation performs the same as the tablet. We will also compare side effects to assess the safety and tolerability, and the effect of food on the test medicine may also be assessed. Blood and urine samples will be collected to conduct safety tests and measure the amount of test medicine.\n \nThis study will take place at one site in Nottingham. Volunteers will stay in the clinic for 7 nights on one occasion, where they will receive the marketed tablet on one occasion and a new liquid formulation on another occasion in a random order. There will then be a minimum washout of 14 days before two further three night stays, each separated by a minimum of 14 days, where they will receive the new liquid formulation with or without food on each occasion. The total time from screening to follow-up call will be approximately 14 weeks.\n
REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0081
Date of REC Opinion
17 May 2024
REC opinion
Further Information Favourable Opinion