Evaluation of the Taste Profile of Ziftomenib (QSC205466)
Research type
Research Study
Full title
A Randomised, Open Label Assessment of the Ziftomenib (KO-539) Capsule Formulation and Ziftomenib Paediatric Product Formulations Taste Profile
IRAS ID
317124
Contact name
Fred D’Amato
Contact email
Sponsor organisation
Kura Oncology Inc.
Duration of Study in the UK
0 years, 1 months, 9 days
Research summary
The Sponsor is developing a new formulation (recipe) of the test product, ziftomenib (also known as KO-539) for the treatment of blood cancers, including acute myeloid leukaemia (AML). AML is a type of cancer that starts in the bone marrow (which makes the body’s red blood cells) and can progress quickly without treatment. The test product has previously been given as a capsule, and the sponsor is now looking to develop an oral liquid formulation (recipe) for adults and children who have difficulty swallowing capsules. Ziftomenib is not marketed in any country.\n\nThis study will look at taste preference of the test product.\n\nThe study will evaluate the palatability attributes and overall acceptability of ziftomenib paediatric product formulations tested with different flavour systems and compared with the ziftomenib capsule formulation tested with water. \n\nIt is planned to enrol 12 healthy male and female of non-childbearing potential volunteers into the study. Volunteers will receive up to 8 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 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 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 7 to 11 days after discharge to ensure the continued wellbeing of volunteers.\n\n\nLay Summary 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.\n\nThis is a basic science study in healthy volunteers, as such there is no requirement to register the study on a public register.\n\nAs this is a basic science study with commercially sensitive results, no further publications or presentations are currently planned.\n\nTissue samples were taken for safety testing only, no samples were collected for future research.\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0334
Date of REC Opinion
23 May 2023
REC opinion
Further Information Favourable Opinion