Sip and spit taste study in healthy volunteers (QSC202640)
Research type
Research Study
Full title
A Two-Part Sip and Spit Taste Study in Male and Female Subjects Designed to Evaluate the Taste Profile of Niraparib Active Pharmaceutical Ingredient Suspension in Both Water and Vehicle and Vehicle with Flavour Systems, and Two Novel Prototypes
IRAS ID
273898
Contact name
Irena McGuffy
Contact email
Sponsor organisation
Tesaro, a GSK company
Duration of Study in the UK
0 years, 10 months, 18 days
Research summary
The Sponsor is developing the test medicine, niraparib, for the potential treatment of cancer in children. Niraparib is available in capsule form, marketed in the UK under the trade name Zejula, and can be prescribed by doctors to treat adult patients with certain types of cancer. The sponsor would now like to improve treatment options for younger cancer patients (0-18 years old).\n\nThe aim of this study is to evaluate the taste of several recipes of niraparib (the test products). These test products may have different flavours and volunteers will be asked to fill out a questionnaire based on how they taste.\n\nThe study will consist of 2 parts, involving 12 healthy male volunteers and female volunteers of non-child bearing potential in each part. \n\nIn Part 1, 12 volunteers will attend the clinical unit on one occasion to taste 8 test products. In Part 2, 12 volunteers will attend the clinical unit on one occasion to taste 3 test products. Each volunteer will be given the test product which they will hold in their mouth for approx. 1 min before it is expectorated (spat out). After each test product, volunteers will then complete a taste questionnaire individually and privately. No test product is to be ingested. There will be a minimum washout of 30 min between each taste test and during this time volunteers will be allowed to cleanse their palates using tap water and unsalted crackers.\n\nIn both parts, volunteers will be discharged the day after the taste tests. Volunteers will have a follow-up phone call 3 to 5 days later to ensure their continued wellbeing.
REC name
Wales REC 2
REC reference
19/WA/0351
Date of REC Opinion
13 Dec 2019
REC opinion
Favourable Opinion