drugset / Trial / NCT02317861
A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients
RandomizedParallel-groupOpen-labelBasic science
Summary
The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in Japanese adult male subjects with gout or asymptomatic hyperuricemia.
Timeline
- Start
- 2014-12
- Primary completion
- 2015-06
- Completion
- 2015-06
Publications
- Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19.
- Shiramoto M, Liu S, Shen Z, Yan X, Yamamoto A, Gillen M, Ito Y, Hall J. Verinurad combined with febuxostat in Japanese adults with gout or asymptomatic hyperuricaemia: a phase 2a, open-label study. Rheumatology (Oxford). 2018 Sep 1;57(9):1602-1610. doi: 10.1093/rheumatology/key100.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benzbromarone | Small molecule | 50 mg | Oral |
| Subject | Febuxostat | Small molecule | 10 mg | Oral |
| Subject | Febuxostat | Small molecule | 20 mg | Oral |
| Subject | Febuxostat | Small molecule | 40 mg | Oral |
| Subject | Verinurad | Small molecule | 2.5 mg | Oral |
| Subject | Verinurad | Small molecule | 5 mg | Oral |
| Subject | Verinurad | Small molecule | 10 mg | Oral |
| Subject | Verinurad | Small molecule | 15 mg | Oral |