NCT02737007

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

A Microdose Study to Describe the Intravenous Pharmacokinetics of GSK3191607 in Healthy Male Subjects Following Administration of [14C]-GSK3191607

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	[14C]-GSK3191607	\[14C\]-GSK3191607 is a solution to be administered intravenously as a single dose infusion over 15 minutes. It is a radio-labeled product; 100 mcg of \[14C\]-GSK3191607 contains approximately 7.4 kilobecquerel (kBq) of \[14C\] radioactivity.

Timeline

• Start date: 2016-04-18
• Primary completion: 2016-05-12
• Completion: 2016-05-12
• First posted: 2016-04-13
• Last updated: 2018-09-13

Locations

1 site across 1 country: United Kingdom