A Microdose Study in Healthy Subjects to Describe Intravenous Pharmacokinetics of GSK3191607

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.

Timeline

Start

2016-04-18

Primary completion

2016-05-12

Completion

2016-05-12

Drugs

Indications