This is a methodology study to examine the quantification of GSK2634673F binding in humans, with the aim of characterising a robust, non-invasive method to quantify the specific binding signal for the alpha(V)beta6 protein in human tissues. This will be the first time that this micro-dose ligand is administered to humans. The study will consist of three parts; Part A, Part B and Part C. Healthy subjects will be recruited into Parts A and B of the study in order to gain experience with the GSK2634673F positron emission tomography (PET) ligand and to optimise the scanning procedures prior to administration to IPF patients in Part C.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
19
GSK2634673F is a synthetic peptide derived from the foot and mouth disease virus (FMDV2). GSK2634673F will be injected into a cubital or forearm vein intravenously and emission data acquired for up to 240 minutes. This radioactive ligand binds potently and specifically to the integrin alpha(V)beta6.
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom
Part A: Radiation effective dose (Millisievert [mSV]/Megabecquerel [MBq]) for whole body
Radiodosimetry will be determined following administration of the GSK2634673F PET radioligand
Time frame: 1 day
Part B and C: Uptake and distribution of GSK2634673F in organs of interest (volume of distribution [VT], binding potential [BP] and/or standardised uptake values [SUV])
The utility of GSK2634673F to quantify integrin alpha(V)beta6 availability in healthy subjects (Part B) and in the lungs of patients with IPF (Part C) will be determined.
Time frame: Up to 2 weeks
Part B: Critical time for scanning post-administration of GSK2634673F
Scanning will be started at the same time as injection of the radioligand and data will be collected for up to 240 minutes
Time frame: 1 day
Part B: Analysis method to quantify integrin alpha(V)beta6 expression from the healthy subject data for use in Part C
Time frame: 1 day
Part C: Qualitative assessment of the relationship between the distribution of fibrosis in the lungs from IPF patients and the uptake of GSK2634673F
High Resolution Computerised Tomography scan (HRCT) of the lungs will be done to allow the potential establishment of areas of fibrosis in the patient lung
Time frame: Up to 2 weeks
Part C: Comparison of VT, BP and/or SUV in IPF versus healthy lungs
Time frame: Up to 2 weeks
Part C: Test/re-test variability of VT, BP and/or SUV
IPF patients may receive a repeat GSK2634673F PET/Computed tomography (CT) in order to determine the variability in αvβ6 expression over time and allow test/re-test variability to be assessed
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 2 weeks