A Study to Assess the Effect of Verinurad on the Electric Activity of the Heart
Condition: Healthy Volunteers (Intended Indication: Chronic Kidney Disease)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Verinurad; Placebo; Allopurinol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Randomized subjects will receive oral dose of verinurad; Randomized subjects will receive oral dose of placebo; Randomized subjects will receive oral dose of allpurinol (Treatment A and B)
Other intervention name(s): verinurad ER 24 mg; verinurad IR 40 mg; verinurad matching placebo; allopurinol matching placebo; allopurinol 300 mg
Intervention MeSH terms: Allopurinol; Verinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomised; Double-Blind; Placebo-Controlled; 3-Period Crossover; Verinurad; Allopurinol; Phase 1