Blood levels of radiolabelled GSK3191607 – first doses in humans v1
Research type
Research Study
Full title
A Microdose Study to Describe the Intravenous Pharmacokinetics of GSK3191607 in Healthy Male Subjects Following Administration of [14C]-GSK3191607 (15-024)
IRAS ID
199907
Contact name
Steve Warrington
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-003655-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
GSK3191607 is a potential new treatment for malaria, which is caused by a parasite. There are other medicines for treating malaria, which work by killing the parasite. But malaria parasites are becoming increasingly resistant to those medicines. GSK3191607 works in a different way from existing medicines so we hope that it will work against parasites that are resistant to other medicines. Also, GSK3191607 works in 2 ways – by killing the parasite at 2 different stages of its lifecycle – so we hope that it will both help patients recover quickly from the illness and prevent spread of the disease. \n\nWe’ll give 6 healthy volunteers, aged 18-55 years, single doses of the study medicine. It’s never been given to humans before, so we’ll give a tiny dose ’microdose’, by slow injection into a vein in the arm. We’ll ‘label’ the study medicine with a small amount of radioactivity, called carbon-14, so that we can detect traces of study medicine in blood and urine. We’re doing this study to find out blood levels of the study medicine, and how the body gets rid of it. We’ll also determine if there are any important side effects of the study medicine. \n\nParticipants will take up to 8 weeks to finish the study. They’ll make up to 10 outpatient visits, and stay on the ward for 3 nights.\n\nA pharmaceutical company GlaxoSmithKline is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
Scotland A REC
REC reference
16/SS/0029
Date of REC Opinion
4 Mar 2016
REC opinion
Favourable Opinion