Absorption and Elimination of Radiolabeled Daprodustat
Status:
Completed
Trial end date:
2017-11-28
Target enrollment:
Participant gender:
Summary
Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in
previous clinical trials; however, the elimination routes and metabolic pathways of
daprodustat have not been fully elucidated in humans. This is an open-label, single-center,
non-randomized, 2-period, single-sequence, crossover, mass balance study in 6 healthy male
participants. The aim of the study is to assess the excretion balance of daprodustat using
[14C]-radiolabeled drug substance administered orally, and as an intravenous (IV) infusion,
administered as a microtracer dose (concomitant with an oral, non-radiolabeled dose).
Absolute bioavailability of an oral dose will also be assessed. Each participant will be
involved in the study for up to 10 weeks which include a screening visit, two treatment
periods (treatment periods 1 and 2), separated by about 7 days (at least 14 days between oral
doses), and a follow up visit 1-2 weeks after the last assessment in treatment period 2. The
primary objective of the study is to gain a better understanding of the compound's excretory
and metabolic profile. This study will include sampling of duodenal bile to conduct
qualitative assessment of drug metabolites in this matrix in order to characterize biliary
elimination pathways.