A Microdose Study in Healthy Subjects to Describe Intravenous Pharmacokinetics of GSK3191607
Status:
Completed
Trial end date:
2016-05-12
Target enrollment:
Participant gender:
Summary
This is an open-label, single-centre, non-randomized study to investigate the
pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy
male subjects.
Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The
study will provide an early readout on human pharmacokinetic parameters. The results of this
study will be used to estimate the potential duration of anti-parasite effect in humans,
define predicted clinical oral doses, and hence inform about the compound's potential safety
margin.
Each subject will participate in the study for up to 8 weeks, and will have a screening
visit, one treatment period, eight outpatient visits, and a follow-up visit.