Safety and PD of RDX227675 in Healthy Volunteers (QCL117611)
Research type
Research Study
Full title
A Phase 1, Single-Center, Randomized, Open-Label, Sodium Polystyrene Sulfonate-Controlled Study to Evaluate the Relative Safety, Tolerability, and Pharmacodynamics of RDX227675 in Healthy Volunteers
IRAS ID
188501
Contact name
David Rosenbaum
Contact email
Sponsor organisation
Ardelyx Inc.
Eudract number
2015-003484-10
Duration of Study in the UK
0 years, 2 months, 8 days
Research summary
Ardelyx (the study Sponsor) is developing an improved drug to treat hyperkalaemia. Hyperkalaemia is a condiiton 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. Ardelyx is developing a product which is expected to have improved taste and texture, and will therefore be more palatable than existing treatments and improve patient compliance. The purpose of this study is to assess the safety and tolerability of the study drug (RDX227675) and to assess the effect of the study drug on potassium levels in the body compared with the currently available treatment (Resonium A).\n\nSixty healthy male or female subjects will be enrolled in this study, and will be divided into 4 groups of 15. In each group, 12 subjects will receive RDX227675 in a specified formulation and 3 will receive Resonium A (the currently available treatment). Treatments will be given 3 times per day; and urine and faecal sample will be collected to assess the effect on potassium levels in the body.
REC name
Wales REC 1
REC reference
15/WA/0300
Date of REC Opinion
25 Sep 2015
REC opinion
Further Information Favourable Opinion