A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to assess the relative bioavailability between the (extended-release)
      ER8 capsule formulation (the formulation that is currently used for verinurad development)
      given under fasted conditions and 2 new capsule formulations of verinurad (A-capsule and
      B-capsule) given under fed or fasted conditions. All three capsules target an 8-hour release
      profile (extended-release). The highest dose (12 mg) currently tested in participants will be
      tested in this study. The study is designed to provide information to optimize the verinurad
      part of a fixed dose combination capsule to be used in future development.
    

Detailed description: 
      This study will be a randomised, open-label, single-dose, 5-period, 5-treatment, crossover
      study in healthy male and female participants, performed at a single study centre. This study
      is intended to assess the relative bioavailability between the ER8 capsule formulation (the
      formulation that is currently used for verinurad development) given under fasted conditions
      and 2 new capsule formulation of verinurad (A-capsule and B-capsule) given under fed or
      fasted conditions. All three capsules target an 8-hour release profile (extended-release).
      The highest dose (12 mg) currently tested in participants will be tested in this study. The
      study is designed to provide information to optimize the verinurad part of a fixed dose
      combination capsule to be used in future development. The study will comprise: a screening
      period of maximum 28 days; five treatment periods during which participants will be resident
      from the morning of the day before dosing with verinurad (Day -1) until at least 72 hours
      after dosing; discharged on the morning of Day 4 of each Treatment Period; and a follow-up
      Visit within 7 to 14 days after the last administration of verinurad. There will be a minimum
      washout period of 5 days between each dose administration. A total of 25 healthy male and
      female participants will be randomised into this study. Each participant will receive five
      single-dose treatments of 12 mg verinurad with 240 mL water, following an overnight fast of
      at least 10 hours. Participants will follow an overnight fast of at least 10 hours before the
      dosing procedures: for the fed dosing, a high-fat, high-calorie standard breakfast will be
      served 30 minutes before the planned administration of verinurad to be consumed in full at
      least 5 minutes before dosing; for the fasted dosing, no breakfast will be served. A meal can
      be given 4 hours after administration of verinurad for both dosing states. The duration of
      the study is expected to be approximately 9 weeks for each individual participant (including
      the 28-day screening period).
    

Intervention name(s): Verinurad ER8 capsule formulation (fasted); Verinurad A-capsule formulation (fasted); Verinurad A-capsule formulation (fed); Verinurad B-capsule formulation (fasted); Verinurad B-capsule formulation (fed)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Each participant will receive single-dose treatment of 12 mg verinurad ER8 capsule with 240 mL water, following an overnight fast of at least 10 hours.; Each participant will receive single-dose treatment of 12 mg verinurad A-capsule with 240 mL water, following an overnight fast of at least 10 hours.; Each participant will receive single dose treatment of 12 mg verinurad A-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast).; Each participant will receive single-dose treatment of 12 mg verinurad B-capsule with 240 mL water, following an overnight fast of at least 10 hours.; Each participant will receive single dose treatment of 12 mg verinurad B-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast).
Intervention MeSH terms: Verinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: URAT1 inhibitor; Uric acid transporter 1; Verinurad; Crossover study; Relative bioavailability; Pharmacokinetics