Healthy Volunteers (Intended Indication: Chronic Kidney Disease) Clinical Trial
Official title:
A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, 3-Period, Cross-Over Phase I Study to Investigate the Effect on the QTcF Interval of a Single Dose of 2 Different Doses of Verinurad, Each in Combination With Allopurinol 300 mg, Compared With Placebo In Healthy Volunteers
This study will be conducted to investigate the safety of verinurad in healthy volunteers in combination with allopurinol 300 mg, compared with placebo in particular its effect on electrocardiogram (ECG), with focus on the QT/QTc interval
This study will be conducted as a single-centre, randomised, placebo-controlled, double-blind, 3-period, crossover study to assess the effect on the QTcF interval of a single oral dose of verinurad 24 mg extended release (ER8) formulation (therapeutic exposure) or verinurad 40 mg immediate release (IR) formulation (supra-therapeutic exposure), each in combination with allopurinol 300 mg, compared to placebo in healthy subjects. There are 3 study treatments: - Treatment A: Verinurad 24 mg ER8 formulation co-administered with 300 mg allopurinol - Treatment B: Verinurad 40 mg IR formulation co-administered with 300 mg allopurinol - Treatment C: Matched placebos for both verinurad and allopurinol All subjects will receive a single dose of all 3 treatments (A, B, and C) in a cross-over design with wash-out periods of at least 7 days between each study dose administration. Subjects will be randomised to the treatment sequence (ABC, BCA, CAB, etc.) using William's Latin square. The treatments will be administered in a double-blind manner after an overnight fast of at least 10 hours. The study will comprise the following periods (visits): - Screening Period of maximum 28 days (Visit 1); - Three treatment periods of 3 days each, during which subjects will be resident at the study centre from the morning of the day before administration of the study dose until discharge 2 days after study dose administration (Visits 2 to 4); - Wash-out periods of at least 7 days between each study dose administration; - Final visit within 7 to 10 days after the last study dose administration (Visit 5). Each subject will be involved in the study for approximately 53 days and have 5 study visits. ;