Absorption and elimination of radiolabelled daprodustat (GSK1278863)
Research type
Research Study
Full title
An open-label study in healthy male participants to determine the mass balance, absolute bioavailability and pharmacokinetics of daprodustat, administered as a single intravenous microtracer (concomitant with an oral dose of non-radiolabelled daprodustat) and a single, oral radiolabelled dose
IRAS ID
229619
Contact name
Frans van den Berg
Contact email
Sponsor organisation
GSK
Eudract number
2017-001729-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine is an experimental treatment for anaemia caused by kidney disease. Anaemia is a condition in which the number or size of red blood cells (which carry oxygen around the body) is lower than normal. People with long-term kidney problems are at risk of developing anaemia. One reason for that is because damage to the kidneys can disrupt signals the body uses to encourage new red blood cells to form. We hope the study medicine will be safer, and more effective, than current treatments for anaemia caused by kidney disease.\nThe study medicine has already been tested in healthy people and patients. We’re doing this study to find out how much of the study medicine gets into the blood stream, how the body gets rid of it, and how long that takes. We’ll also determine if it has any important side effects.\n\nWe’ll study 6 healthy men, aged 30–55 years. Participants will have 2 study sessions. In session 1, they’ll receive a tiny ‘microdose’, by slow injection into a vein, alongside a normal dose, as a tablet, by mouth. In session 2, they’ll receive another dose of the study medicine, as a liquid, by mouth. We’ll ‘label’ the study medicine with a small amount of radioactivity, called carbon-14, so that we can detect traces of it, and its breakdown products, in blood, urine, faeces (‘poo’) and bile.\n\nParticipants will take up to 10 weeks to finish the study. They’ll make 2 outpatient visits, and stay on the ward for 15 nights (7 nights in session 1; 8 nights in session 2). They might stay on the ward for longer session 2, depending on the results.\n\nA pharmaceutical company (GlaxoSmithKline) is funding the study.\n\nThe study will take place at 1 centre in London.\n
REC name
HSC REC A
REC reference
17/NI/0104
Date of REC Opinion
25 Jul 2017
REC opinion
Further Information Favourable Opinion