drugset / Trial / NCT04024501

A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition

NCT04024501

Phase 1 Completed 25 enrolled AstraZeneca
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2019-07-20
Primary completion
2019-09-18
Completion
2019-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Verinurad Small molecule 12 mg