Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with febuxostat in adults with gout: a phase IIa, open-label study.

ABSTRACT:

Objective

Verinurad (RDEA3170) is a high-affinity, selective URAT1 inhibitor in development for treating gout and asymptomatic hyperuricaemia. This study evaluated the pharmacodynamics, pharmacokinetics and safety of verinurad in combination with febuxostat in adults with gout.

Methods

The phase IIa, open-label, multicentre study randomised 64 subjects into one of five cohorts to receive febuxostat (40 or 80 mg) alone or in combination with verinurad 2.5-20 mg. Serial plasma/serum and urine samples were assayed for verinurad and uric acid. Safety was assessed by adverse events, chemistry panels, ECGs and physical examinations.

Results

Serum pharmacodynamic data demonstrated the maximum percent decrease in serum urate (sUA) from baseline (E_max) at 8-12 hours

SUBMITTER: Fleischmann R 

PROVIDER: S-EPMC5892780 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature