Single doses of GSK3008348 in IPF patients using PET imaging
Research type
Research Study
Full title
A study of single doses to evaluate the safety, tolerability, pharmacokinetics and target engagement of nebulised GSK3008348 in idiopathic pulmonary fibrosis patients, using positron emission tomography (PET) imaging
IRAS ID
221453
Contact name
Toby Maher
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2016-003674-41
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Study 204715 will investigate an experimental study drug, GSK3008348, for the treatment of idiopathic pulmonary fibrosis (IPF), a condition that causes scarring of the lung. GSK3008348 has not been given to IPF patients before, but it has been given to 27 healthy volunteers in another clinical study.
We aim to test whether GSK3008348 binds to “αvβ6 integrin” in the lungs of people with IPF, using a type of imaging scan called positron emission tomography (PET). αvβ6 integrin is thought to play an important role in the development of scarring in the lungs. We hope in later studies to show that GSK3008348 will slow progression of the disease. We will also investigate whether GSK3008348 has any side effects in people with IPF, how much GSK3008348 gets into the bloodstream, and how quickly the body gets rid of it.
Up to 21 people in the UK will take part in this study, in 2 groups (Groups 1 and 2). Participants will have 2 study sessions, and will take a single dose of GSK3008348 in each session. In study session 1, we will collect information on the safety of GSK3008348, and take blood and urine samples to check the levels of GSK3008348. In study session 2, participants will have up to 3 PET scans to see how much of the study drug binds to the αvβ6 integrin in the lungs.
Participants will be in the study for up to 10 weeks. Group 1 will have 1 overnight stay at the hospital and make 6 outpatient visits. Group 2 will make up to 8 outpatient visits.
The study will take place at specialist IPF hospitals or clinics in London, UK. The PET scan visits will take place at Imanova Ltd, London, a medical imaging centre. A pharmaceutical company, GlaxoSmithKline, is paying for the study.REC name
London - Central Research Ethics Committee
REC reference
17/LO/0284
Date of REC Opinion
23 Mar 2017
REC opinion
Further Information Favourable Opinion