Kidney Disease Clinical Trial
Official title:
A Phase I, Single-Dose, Randomized and Single-Blind (Part 1), Fixed Sequence and Open-Label (Part 2), Studyto Evaluate the Safety, Pharmacokinetics, andPharmacodynamics of 1278863A in Subjects With RenalImpairment and Matched Healthy Volunteers
The purpose of this study is to characterize the safety and tolerability of single doses of compound 1278863A in subjects with renal impairment.
Compound 1278863A is a novel small molecule agent, which stimulates erythropoiesis through inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is being developed for the treatment of anemia. This study, PHI112843, will be the first administration of 1278863A to investigate the safety, tolerability, pharmacokinetics and/or pharmacodynamics of single oral doses of 50 mg and 150 mg in pre-dialysis subjects with moderate or severe renal impairment and 150 mg in hemodialysis-dependent subjects. Four to eight subjects will complete each dose cohort. Multiple blood samples for pharmacokinetic and/or pharmacodynamic analyses will be obtained post-dose in each cohort. Safety will be assessed by measurement of vital signs, cardiac monitoring, collection of adverse event assessments and laboratory safety tests. ;
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