Taste and Acceptability Study of Nabiximols Formulations (QSC204915)
Research type
Research Study
Full title
A Single Site, Randomized, Single-blind 6 Treatment Sequence Crossover Study to Evaluate the Taste Attributes and Overall Acceptability of Nabiximols Formulations in Healthy Volunteers using a Spray-and-Expel Methodology
IRAS ID
296298
Contact name
Georgina Wells
Contact email
Sponsor organisation
GW Pharma Ltd.
Duration of Study in the UK
0 years, 1 months, 15 days
Research summary
Research Summary
Nabiximols is an oromucosal spray, approved for use in multiple countries, including most EU countries and Canada for patients with moderate to severe spasticity due to multiple sclerosis (MS) that has not responded to other anti-spasticity medication, under the trade name Savitex. Patient compliance for Savitex is lower than desired, likely due to poor palatability. Therefore, the Sponsor are conducting this study to assess taste attributes and overall acceptability of the test product formulations (nabiximols with flavourings).The study consists of two periods involving up to 18 healthy male and female volunteers. In Period 1 volunteers will taste test products on six occasions over two days, in Period 2 volunteers will taste test products on three occasions in one day.
In both periods, volunteers will receive a single spray of the test product or Savitex reference on each tasting occasion, which they will hold in their mouth for approximately 30 seconds before it is expelled. After each tasting occasion, volunteers will complete a taste questionnaire individually and privately. No test product is to be ingested. There will be a minimum washout of 5 hours between each taste test, during this time volunteers will be allowed to cleanse their palates using water and unsalted crackers. A maximum of three taste tests will be performed each day. Volunteers will be discharged from the clinical unit 48-hours after their first dose in Period 1 and 24-hours after first dose in Period 2.
Data from Period 1 will be used to determine which flavour combinations may lead to a better taste profile, these will be tested in Period 2. There will be a minimum of 14 days between Periods 1 and 2 to allow for this data review.
A follow-up call will take place 3-7 days post-final administration to ensure the ongoing wellbeing of participants.
Summary of Results
Due to the sensitivity and confidentially of the data obtained, it is Sponsor’s preference to not disclose a summary of results.REC name
HSC REC A
REC reference
21/NI/0073
Date of REC Opinion
5 May 2021
REC opinion
Favourable Opinion