A Sensory Evaluation of the Dispersible Formulation of Tafenoquine
Research type
Research Study
Full title
A Sensory Evaluation of the Dispersible Formulation of Tafenoquine
IRAS ID
259728
Contact name
Vicki Rousell
Contact email
Sponsor organisation
GlaxoSmithKline
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
Tafenoquine has been developed by GlaxoSmithKline (GSK) to treat malaria caused by the parasite Plasmodium vivax. Tafenoquine in adults is licensed in the US and Australia. Currently, GSK are conducting clinical trials in children using a dispersible (dissolved in liquid) paediatric (child) formulation of this drug. During these trials, around 24% of participants who received tafenoquine reported vomiting. Vomiting is common in malaria and it is difficult to tell if the vomiting is due to the drug’s sensory profile, or the child’s medical condition.
This study aims to evaluate the sensory profile of paediatric dispersible tablets to identify ways this may be modified to provide guidance to healthcare workers when giving to children. This will be done using sensory assessments that do not involve swallowing the product. To assess this, a minimum of 12 adult sensory panellists trained and employed by GSK Consumer Health Sensory Laboratory will participate in this study.
All participants will be screened at the GSK Clinical Unit Cambridge (CUC) prior to the assessments to eliminate any risk associated with accidental ingestion. Sensory assessments will be performed at the GSK Consumer Health Sensory Laboratory (Brentford, UK), using solutions of different concentrations and liquids, prepared using 50mg dispersible paediatric tablets or placebo. Each panellist will test a maximum of 6 solutions a day, repeated in triplicate across 3 days. The panellist will pour the solution into their mouth and swirl it for 15 seconds. They will then tilt their head back and hold the liquid at the back of their throat for 5 seconds before returning their head to a normal position and expectorating. They will be asked to respond on a scale of 0-9 for a range of sensory attributes. This method of sensory assessment has been demonstrated to produce a similar sensory profile to ingestion.REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/0467
Date of REC Opinion
20 Mar 2019
REC opinion
Favourable Opinion