drugset / Trial / NCT04024501
A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Verinurad | Small molecule | 12 mg | — |