A PET scan study of GSK2256098; ver 1
Research type
Research Study
Full title
A microdose Study to Evaluate the Biodistribution of [11C]-GSK2256098 in the Lungs and Heart of Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients using Positron Emission Tomography (PET) HMR code (15-505)
IRAS ID
184983
Contact name
Adeep Puri
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-002626-40
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
GSK2256098 is an experimental new medicine for treating pulmonary arterial hypertension (PAH). GSK2256098 blocks a substance called focal adhesion kinase (FAK), which may play a part in the process that causes stiffening of blood vessels in PAH. If FAK does have a role in that process, levels of FAK in the heart and lungs are likely to be higher in patients with PAH than in healthy people. So, we’re doing this study to compare levels of FAK in healthy people and patients with PAH. We also want to check that GSK2256098 can reach FAK in the heart and lungs.
To measure FAK in the hearts and lungs, we’ll use a tiny dose of GSK2256098 that’s been labelled with radioactivity (carbon-11-GSK2256098 – the study tracer). We’ll do a type of scan called a PET (positron emission tomography) scan, which makes images of the body.We’ll test the tracer in men and women aged 40-70 as follows:
•up to 12 healthy participants; and
•up to 12 patients with PAH.Healthy participants and patients will have 1 dose of tracer and 1 PET scan. They’ll make 3 outpatient visits and take up to 8 weeks to finish the study.
A pharmaceutical company (GlaxoSmithKline) is funding the study.
Participants will be recruited and screened at Hammersmith Medicines Research, London, and have PET scans at Imanova, London. We’ll recruit healthy people by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites. Hospital consultants will help us recruit patients with PAH.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0446
Date of REC Opinion
18 Sep 2015
REC opinion
Further Information Favourable Opinion