Daprodustat is a prolyl hydroxylase inhibitor that stimulates erythropoiesis in 
a manner similar to the natural response to hypoxia, whereby inhibition of 
hypoxia inducible factor (HIF) prolyl-4-hydroxylases by daprodustat ultimately 
results in increased levels of HIF-responsive genes. Daprodustat is under 
development as an emerging new class of agents for the treatment of anemia 
associated with chronic kidney disease (CKD). This was a single-center, 
single-dose, open-label, randomized, 2-way crossover study in healthy Japanese 
male participants consisting of 2 parts. The primary objective was to evaluate 
the bioequivalence (BE) between daprodustat tablet strengths (part 1) and to 
evaluate the food effect on the pharmacokinetics (PK) of daprodustat (part 2). A 
total of 64 healthy Japanese male participants were enrolled; 52 participants 
were included in part 1 and 12 in part 2. BE was demonstrated between the 
daprodustat 2-mg tablet and the daprodustat 4-mg tablet. A standard CKD meal did 
not have a large effect on the PK parameters of daprodustat after a single oral 
dose of daprodustat 4 mg. Administration of single oral doses of daprodustat 4 
mg was generally well tolerated in the healthy Japanese participants, and no new 
safety signals were identified without regard to food.