ogt2378 and Renal-Insufficiency

ogt2378 has been researched along with Renal-Insufficiency* in 1 studies

Trials

1 trial(s) available for ogt2378 and Renal-Insufficiency

ArticleYear
Effect of Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of the Iminosugar Sinbaglustat.
    Journal of clinical pharmacology, 2021, Volume: 61, Issue:7

    Sinbaglustat (ACT-519276), a brain-penetrating inhibitor of glucosylceramide synthase and nonlysosomal glucosylceramidase, is developed as a new therapy for lysosomal storage disorders. In the first-in-human study, sinbaglustat was primarily excreted unchanged in urine. This study was conducted to evaluate the effect of mild, moderate, and severe renal function impairment on the safety, tolerability, and pharmacokinetics (PK) of sinbaglustat. In this single-center, open-label study, 32 subjects (8 per renal function group, assessed by the Cockcroft-Gault formula, and 8 healthy subjects) received a single oral dose of 200 mg sinbaglustat. Plasma PK parameters of sinbaglustat were derived by noncompartmental analysis. Standard safety and tolerability evaluations were analyzed descriptively. When compared with healthy subjects, C

    Topics: Aged; Area Under Curve; Dose-Response Relationship, Drug; Female; Humans; Imino Sugars; Male; Metabolic Clearance Rate; Middle Aged; Patient Acuity; Piperidines; Renal Insufficiency

2021