Ignite Creation Date:
2024-05-06 @ 7:33 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02551653
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2015-09-14
Brief Title:
Positron Emission Tomography PET Study to Evaluate Biodistribution of 11C-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension PAH Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary arterial hypertension PAH involves the narrowing of blood vessels connected to and within the lungs Focal adhesion kinase FAK is a focal adhesion-associated protein kinase involved in cellular adhesion and spreading processes which leads to stiffening and thickening of blood vessels in lungs This further increases the blood pressure within the lungs and impairs their blood flow This study aims to demonstrate biodistribution of FAK inhibitor GSK2256098 in cardiopulmonary sites ie heart and lung tissues The uptake of 11C-radiolabelled GSK2256098 within the lung and or heart of healthy subjects and idiopathic pulmonary arterial hypertension iPAH patients will be assessed using Positron Emission Tomography PET Based on study results the decision as to whether a follow-on phase 2 trial should be initiated to investigate the therapeutic utility of GSK2256098 in iPAH will be decided Sufficient number of subjects will be screened up to 30 days prior to scan to enrol 12 healthy subjects and 12 PAH patients in the study Enrolled subjects will receive a microdose of 11C-GSK2256098 on a scanning day which will be followed by the follow-up visit 2-4 weeks post-last dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None