Study to Evaluate the Taste Profile of Ca PSS (QCL117420)

• Research type

  Research Study

• Full title

  A Phase I Randomised Study to Evaluate the Overall Consumer Acceptability of Taste and Mouth Feel of Oral Calcium Polystyrene Sulphonate Resin Based Formulation in Healthy Subjects

• IRAS ID

  183601

• Contact name

  David Rosenbaum

• Sponsor organisation

  Ardelyx, Inc

• Duration of Study in the UK

  0 years, 1 months, 0 days

• Research summary

  Ardelyx (the Study Sponsor) is developing an improved drug to treat hyperkalaemia. Hyperkalaemia is a condition in which the amount of potassium in the blood is elevated, which can cause palpitations, malaise and muscle weakness. Extreme hyperkalaemia can cause fatal heart problems. Currently available treatments are found to be unpalatable to patients, both in taste and texture. The product in this study is expected to have improved taste and texture, and the purpose of this study is to identify an optimal taste and thickness of the product for use in future trials.

  Twenty healthy male or female volunteers will each receive 9 different flavours and/or thicknesses of CaPSS and 1 reference product (an existing treatment for hyperkalaemia) over two sessions. The volunteers will complete a questionnaire to assess the taste and palatability of each different product.

• REC name

  Wales REC 2

• REC reference

  15/WA/0192

• Date of REC Opinion

  23 Jun 2015

• REC opinion

  Further Information Favourable Opinion