A Phase 1, Open-label, Non-randomized, Parallel Group, Single-dose Adaptive Study in Adults With Hepatic Impairment and Matched, Healthy Control Participants With Normal Hepatic Function
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https://search.vivli.org/doiLanding/studies/PR00009266/isLanding
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资源简介:
Daprodustat (GSK1278863), is a small molecule currently in development for the treatment of
anemia of chronic kidney disease (CKD). Results of the earlier studies shows that liver is
involved in the clearance of Daprodustat and hence, hepatic impairment can affect Daprodustat
levels in the body. This single dose study will assess the effect of liver impairment on the
pharmacokinetics (PK) and pharmacodynamics (PD) of daprodustat. The study will be conducted
in two parts, Part 1 will include subjects with moderate hepatic impairment and matched
healthy control subjects whereas Part 2 will include subjects will either mild or severe
hepatic impairment and matched healthy control subjects. Approximately 8 subjects will be
included in each of the group and all subjects will receive 6 milligram (mg) of daprodustat
as a single oral dose in the fasted state. Total duration of participation in the study for a
subject will be up to 7 weeks.
提供机构:
Vivli
创建时间:
2023-09-12



