A Positron Emission Tomography (PET) Study to Investigate the Brain Biodistribution of 18F GSK2647544 in Healthy Subjects to Determine Its Ability to Cross the Blood-brain-barrier.
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|ClinicalTrials.gov Identifier: NCT01924858|
Recruitment Status : Terminated (Study objectives met so study concluded earlier than planned hence we terminated the study.)
First Posted : August 19, 2013
Last Update Posted : October 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: GSK2647544 oral Drug: [18F]GSK2647544 IV bolus||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Positron Emission Tomography (PET) Study to Investigate the Brain Biodistribution of 18F-GSK2647544 in Healthy Subjects|
|Actual Study Start Date :||August 19, 2013|
|Actual Primary Completion Date :||March 3, 2014|
|Actual Study Completion Date :||March 3, 2014|
Experimental: GSK2647544 oral and [18F]GSK2647544 IV bolus
All subjects will receive a single oral dose of GSK2647544 100 milligram (mg) approximately 2 hours before administration of [18F] GSK2647544 and a dynamic PET scan. [18F]-GSK2647544 will be administered to the subject as an IV bolus during the PET scan, which will be conducted for up to 120 minute post the injection of [18F]GSK2647544
Drug: GSK2647544 oral
GSK2647544 100 mg will be supplied as a size 0 swedish orange hard gelatin capsules filled with white/slightly colored granule. Subjects will receive a single oral dose of GSK2647544 100 mg (2 X 50mg capsules) with 150 mL of tepid water approximately 2 hours prior to the IV infusion of [18F]-GSK2647544 and a PET scan.
Drug: [18F]GSK2647544 IV bolus
[18F]GSK2647544 will be supplied as a clear, colourless solution free from visible particle. A maximum dose up to 2 mg with a maximum dose volume of 25 mL will be administered as IV bolus over 60 seconds.
- Whole brain PET VT of [18F]-GSK2647544 [ Time Frame: At Day 1 ]The subject will be administered GSK2647544 radiolabelled with fluorine-18 ([18F]-GSK2647544) to determine the ratio of the concentration of the compound in tissue to that in plasma at equilibrium, expressed as the PET VT
- Safety and tolerability assessment following oral administration of GSK2647544 [ Time Frame: Up to Day 14 ]The safety and tolerability assessment including adverse events assessment; clinical hematology, clinical chemistry, urinalysis and renal function tests; single 12-lead electrocardiograms (ECGs) and vital sign measurements including systolic and diastolic blood pressure (BP), pulse rate and respiratory rate.
- GSK2647544 PK assessment [ Time Frame: Pre dose and at 30minute, 1, 2, 4, 6 hours post dose on Day 1 ]Blood sample will be collected for PK analysis of GSK2647544 including maximum observed plasma concentration (Cmax) and time to Cmax (tmax).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924858
|GSK Investigational Site|
|London, United Kingdom, NW10 7EW|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|