NCT04550234

A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol

A Randomised, Single Dose, 5-period, 5-treatment, Crossover Study to Assess the Relative Bioavailability of 4 Different Formulations of Verinurad and Allopurinol in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a single centre, randomised, open-label, single-dose, 5-period, 5-treatment, crossover study in healthy male and female subjects. This study is intended to assess the relative bioavailability between the fixed dose combination (FDC, i.e. verinurad/allopurinol FDC capsule 12/300 mg) and free combination formulations of verinurad (i.e. verinurad prolonged release Hydroxypropyl methylcellulose \[HPMC\] capsule 12 mg) and allopurinol (i.e. allopurinol table 300 mg) in fasted and fed conditions. The study will also assess the relative bioavailability between a formulation only containing verinurad (i.e. verinurad prolonged release gelatin capsule 12 mg) and the FDC capsule.

Detailed description

The study comprises of: * A Screening Period of maximum 28 days; * Five treatment periods during which subjects will be resident from the morning of Day -2 until at least 72 hours after dosing in Treatment Period 5; discharged on the morning of Day 4 of Treatment Period 5; and * A Follow-up Visit 7 to 14 days after the last dosing. Each subject will receive 5 single dose treatments of verinurad and allopurinol or verinurad alone and subject will be involved in the study for 52 to 59 days.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Verinurad prolonged release HPMC capsule	Randomized subjects will receive oral dose of verinurad HPMC capsule.
DRUG	Allopurinol Tablet	Randomized subjects will receive oral dose of allopurinol tablet.
DRUG	Verinurad/Allopurinol FDC Capsule	Randomized subjects will receive oral dose of Verinurad/Allopurinol FDC capsule.
DRUG	Verinurad prolonged release gelatin Capsule	Randomized subjects will receive oral dose of Verinurad gelatin capsule.

Timeline

• Start date: 2021-04-13
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2020-09-16
• Last updated: 2023-05-10
• Results posted: 2023-05-10

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study