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

NCT ID: NCT02737007


Title
A Microdose Study to Describe the Intravenous Pharmacokinetics of GSK3191607 in Healthy Male Subjects Following Administration of [14C]-GSK3191607
Purpose
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.
Details
Conditions
Malaria, Falciparum
Keywords
Malaria, Microdose, GSK3191607
Source
GlaxoSmithKline
Sponsors
GlaxoSmithKline, Hammersmith Medicines Research
Status
Completed
Acronym
Last Updated
15 Jan 2017
URL
Official Link
Locations
United Kingdom