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The study was terminated due to challenges recruiting subjects with fibrotic interstitial lung disease associated with a connective tissue disease for Part D
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Other | In Part A, up to 6 healthy subjects will be enrolled in order to determine the human radiodosimetry following administration of the PET radioligand. |
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| Part B | Other | In Part B, up to 8 healthy subjects will be recruited to provide sufficient PET data to quantify the uptake and distribution of GSK2634673F in healthy subjects. |
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| Part C | Other | In Part C, up to 20 IPF subjects will be recruited to provide sufficient PET data to quantify the uptake and distribution of GSK2634673F in IPF subjects and, if appropriate, potentially quantify the test/re-test variability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2634673F | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Radiation effective dose (Millisievert [mSV]/Megabecquerel [MBq]) for whole body | Radiodosimetry will be determined following administration of the GSK2634673F PET radioligand | 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. | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| Part B: Analysis method to quantify integrin alpha(V)beta6 expression from the healthy subject data for use in Part C |
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Inclusion Criteria:
Additional Inclusion Criteria for Part A and B (healthy subjects):
Additional Inclusion Criteria for Part C (IPF subjects):
Exclusion Criteria:
Criteria Based Upon Medical Histories
Criteria Based Upon Diagnostic Assessments
Other Criteria
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | NW10 7EW | United Kingdom | |||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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 | Up to 2 weeks |
| Part C: Comparison of VT, BP and/or SUV in IPF versus healthy lungs | 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 | Up to 2 weeks |
| London |
| W12 0NN |
| United Kingdom |