drugset / Trial / NCT02246673
RDEA3170 and Febuxostat Combination Study in Gout Subjects
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-07
- Completion
- 2016-02
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.
- Fleischmann R, Winkle P, Hall J, Valdez S, Liu S, Yan X, Hicks L, Lee C, Miner JN, Gillen M, Hernandez-Illas M. Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with febuxostat in adults with gout: a phase IIa, open-label study. RMD Open. 2018 Apr 9;4(1):e000647. doi: 10.1136/rmdopen-2018-000647. eCollection 2018.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Febuxostat | Small molecule | 40 mg | Oral |
| Subject | Febuxostat | Small molecule | 80 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 |