Back to Search
Start Over
Clinical pharmacological study of dotinurad administered to male and female elderly or young subjects.
- Source :
-
Clinical and experimental nephrology [Clin Exp Nephrol] 2020 Mar; Vol. 24 (Suppl 1), pp. 8-16. Date of Electronic Publication: 2019 Dec 30. - Publication Year :
- 2020
-
Abstract
- Background: Dotinurad is a novel selective urate reabsorption inhibitor (SURI) that selectively inhibits the reabsorption of uric acid in renal tubules and promotes the excretion of uric acid into urine. In this study, the effects of age and gender on the pharmacokinetics (PK), pharmacodynamics (PD), and safety of dotinurad were evaluated in healthy subjects.<br />Methods: An open-label study of a single oral administration of dotinurad 1 mg was conducted in elderly (≥ 65 years) Japanese males and females, and young (20-35 years) males and females (six patients each).<br />Results: Following a single-dose administration of dotinurad, the change in dotinurad plasma concentration showed a similar profile across groups. Regarding the PK parameters, there was no significant difference between elderly and young subjects. On comparing males and females, significant differences were observed in some parameters in elderly subjects. However, these differences in some parameters could not be detected by adjust for body weight. When PD parameters in elderly and young subjects were compared, significant differences were observed in some parameters in male subjects. On comparing males and females, significant differences were observed in some parameters in young subjects; however, the percent change in serum uric acid concentration decreased over time was relatively close for both groups. There were no clinically relevant safety problems.<br />Conclusion: Age and gender had no clinically meaningful effect on the PK, PD, and safety of dotinurad.<br />Clinical Trials: ClinicalTrials.gov identifier: NCT02344875.
- Subjects :
- Adult
Age Factors
Aged
Benzothiazoles adverse effects
Female
Glucuronides blood
Glucuronides urine
Healthy Volunteers
Humans
Japan
Male
Metabolic Clearance Rate
Sex Factors
Sulfates blood
Sulfates urine
Uric Acid blood
Uric Acid urine
Young Adult
Benzothiazoles administration & dosage
Uricosuric Agents administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1437-7799
- Volume :
- 24
- Issue :
- Suppl 1
- Database :
- MEDLINE
- Journal :
- Clinical and experimental nephrology
- Publication Type :
- Academic Journal
- Accession number :
- 31889230
- Full Text :
- https://doi.org/10.1007/s10157-019-01836-0