Trial Outcomes & Findings for A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects (NCT NCT02829307)
NCT ID: NCT02829307
Last Updated: 2018-09-07
Results Overview
SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time. SUV was analyzed for each region of interest (ROI) such as liver, kidney, muscle, spleen, heart, lung, bladder, thymus, and if feasible blood and bone. A maximum of 4 PET scans were conducted in each participant. Mean SUV derived from PET-CT has been presented.
COMPLETED
PHASE1
8 participants
Up to Day 7
2018-09-07
Participant Flow
This study was conducted at a single center in Netherlands from 23-Aug-16 to 27-Jan-17. A total of 8 participants were randomized in the study who received 89Zr-GSK3128349 which was a mixture of unlabelled and zirconium-labelled GSK3128349, in the form of solution for intravenous (IV) administration.
A total of 34 participants were screened, of which 26 were screen failures. The reasons for screen failure were: did not meet the inclusion/exclusion criteria (11 participants) and investigator discretion (15 participants).
Participant milestones
| Measure |
89Zr-GSK3128349
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 milligram (mg).
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|---|---|
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
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|---|---|
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Age, Continuous
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55.0 Years
STANDARD_DEVIATION 2.33 • n=93 Participants
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Sex: Female, Male
Female
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0 Participants
n=93 Participants
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Sex: Female, Male
Male
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8 Participants
n=93 Participants
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Race/Ethnicity, Customized
American Indian or Alaskan Native
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1 Participants
n=93 Participants
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Race/Ethnicity, Customized
White- White/Caucasian/ European Heritage
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7 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Up to Day 7Population: Pharmacokinetic (PK) Population comprised of participants in the Safety Population for whom a PK sample was obtained and analyzed, and/or for which a PET scan was completed. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time. SUV was analyzed for each region of interest (ROI) such as liver, kidney, muscle, spleen, heart, lung, bladder, thymus, and if feasible blood and bone. A maximum of 4 PET scans were conducted in each participant. Mean SUV derived from PET-CT has been presented.
Outcome measures
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Thigh muscle: PET scan 1; n=8
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0.515 Ratio
Standard Deviation 0.1387
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Thigh muscle: PET scan 2; n=8
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0.566 Ratio
Standard Deviation 0.1315
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|
Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Thigh muscle: PET scan 3; n=7
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0.607 Ratio
Standard Deviation 0.0767
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Thigh muscle: PET scan 4; n=7
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0.623 Ratio
Standard Deviation 0.1509
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Liver: PET scan 1; n=8
|
4.929 Ratio
Standard Deviation 0.7219
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Liver: PET scan 2; n=8
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3.231 Ratio
Standard Deviation 0.4981
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Liver: PET scan 3; n=7
|
2.994 Ratio
Standard Deviation 0.7314
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Liver: PET scan 4; n=7
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2.280 Ratio
Standard Deviation 0.3151
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Pancreas: PET scan 1; n=7
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2.177 Ratio
Standard Deviation 0.4573
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Pancreas: PET scan 2; n=7
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2.029 Ratio
Standard Deviation 0.6621
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Pancreas: PET scan 3; n=6
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1.887 Ratio
Standard Deviation 0.4131
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Pancreas: PET scan 4; n=6
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1.917 Ratio
Standard Deviation 1.0314
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Thyroid gland: PET scan 1; n=8
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2.338 Ratio
Standard Deviation 0.8821
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Thyroid gland: PET scan 2; n=8
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2.171 Ratio
Standard Deviation 0.8408
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Thyroid gland: PET scan 3; n=7
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2.330 Ratio
Standard Deviation 1.0510
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Thyroid gland: PET scan 4; n=7
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1.789 Ratio
Standard Deviation 0.4791
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Testis: PET scan 1; n=8
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3.336 Ratio
Standard Deviation 0.7479
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|
Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Testis: PET scan 2; n=8
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3.733 Ratio
Standard Deviation 0.7793
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Testis: PET scan 3; n=7
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3.259 Ratio
Standard Deviation 0.9988
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Testis: PET scan 4; n=7
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3.280 Ratio
Standard Deviation 0.4789
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Bladder: PET scan 1; n=8
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2.750 Ratio
Standard Deviation 1.0483
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Bladder: PET scan 2; n=8
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1.149 Ratio
Standard Deviation 0.4572
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Bladder: PET scan 3; n=7
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1.630 Ratio
Standard Deviation 0.4938
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Bladder: PET scan 4; n=7
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1.609 Ratio
Standard Deviation 0.4176
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney: PET scan 1; n=8
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7.845 Ratio
Standard Deviation 1.1487
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney: PET scan 2; n=8
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9.516 Ratio
Standard Deviation 1.0005
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney: PET scan 3; n=7
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10.466 Ratio
Standard Deviation 2.2765
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney: PET scan 4; n=7
|
8.603 Ratio
Standard Deviation 1.6626
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Parotid gland: PET scan 1; n=8
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1.514 Ratio
Standard Deviation 0.3005
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Parotid gland: PET scan 2; n=8
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1.430 Ratio
Standard Deviation 0.3091
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Parotid gland: PET scan 3; n=7
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1.541 Ratio
Standard Deviation 0.2084
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Parotid gland: PET scan 4; n=7
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1.531 Ratio
Standard Deviation 0.1643
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Bone marrow: PET scan 1; n=8
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1.746 Ratio
Standard Deviation 0.2575
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Bone marrow: PET scan 2; n=8
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1.378 Ratio
Standard Deviation 0.2066
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Bone marrow: PET scan 3; n=7
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1.289 Ratio
Standard Deviation 0.2998
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Bone marrow: PET scan 4; n=7
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1.350 Ratio
Standard Deviation 0.2802
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Spleen: PET scan 1; n=8
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5.220 Ratio
Standard Deviation 0.6398
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Spleen: PET scan 2; n=8
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3.691 Ratio
Standard Deviation 0.4638
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Spleen: PET scan 3; n=7
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3.296 Ratio
Standard Deviation 0.8611
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Spleen: PET scan 4; n=7
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3.097 Ratio
Standard Deviation 0.4946
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Brain: PET scan 1; n=8
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0.461 Ratio
Standard Deviation 0.0762
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Brain: PET scan 2; n=8
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0.295 Ratio
Standard Deviation 0.0901
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Brain: PET scan 3; n=7
|
0.231 Ratio
Standard Deviation 0.0689
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Brain: PET scan 4; n=7
|
0.201 Ratio
Standard Deviation 0.0348
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Lung: PET scan 1; n=8
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1.884 Ratio
Standard Deviation 0.5968
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Lung: PET scan 2; n=8
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1.345 Ratio
Standard Deviation 0.4381
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Lung: PET scan 3; n=7
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1.186 Ratio
Standard Deviation 0.4720
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Lung: PET scan 4; n=7
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0.893 Ratio
Standard Deviation 0.2583
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Aorta: PET scan 1; n=8
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10.835 Ratio
Standard Deviation 2.0289
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Aorta: PET scan 2; n=8
|
6.573 Ratio
Standard Deviation 1.5621
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Aorta: PET scan 3; n=7
|
5.516 Ratio
Standard Deviation 1.4879
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Aorta: PET scan 4; n=7
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4.299 Ratio
Standard Deviation 0.8195
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Heart: PET scan 1; n=8
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8.601 Ratio
Standard Deviation 1.8566
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Heart: PET scan 2; n=8
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5.851 Ratio
Standard Deviation 1.5742
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Heart: PET scan 3; n=7
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4.829 Ratio
Standard Deviation 1.3661
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Heart: PET scan 4; n=7
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3.701 Ratio
Standard Deviation 0.6770
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney, cortex: PET scan 1; n=8
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8.805 Ratio
Standard Deviation 1.4835
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney, cortex: PET scan 2; n=8
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12.145 Ratio
Standard Deviation 1.7704
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney, cortex: PET scan 3; n=7
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11.966 Ratio
Standard Deviation 1.5492
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney, cortex: PET scan 4; n=7
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10.479 Ratio
Standard Deviation 1.6047
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney, medulla: PET scan 1; n=8
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6.996 Ratio
Standard Deviation 1.5577
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney, medulla: PET scan 2; n=8
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7.416 Ratio
Standard Deviation 1.2101
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney, medulla: PET scan 3; n=7
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8.247 Ratio
Standard Deviation 2.3436
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Kidney, medulla: PET scan 4; n=7
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6.691 Ratio
Standard Deviation 1.1767
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Body: PET scan 1; n=8
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0.739 Ratio
Standard Deviation 0.1647
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Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Body: PET scan 2; n=8
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0.654 Ratio
Standard Deviation 0.1632
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|
Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Body: PET scan 3; n=7
|
0.701 Ratio
Standard Deviation 0.1728
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|
Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Body: PET scan 4; n=7
|
0.631 Ratio
Standard Deviation 0.1680
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PRIMARY outcome
Timeframe: Up to Day 7Population: PK Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Volume of ROI is the volume specified in organs as measured in PET or CT images. Mean volume of ROI for each organ has been presented.
Outcome measures
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
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|---|---|
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Mean Volume of ROI for Each Organ at All Time Points
Kidney, cortex: PET scan 3; n=7
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6.770 Milliliter (mL)
Standard Deviation 1.2609
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Mean Volume of ROI for Each Organ at All Time Points
Thigh muscle: PET scan 1; n=8
|
45.001 Milliliter (mL)
Standard Deviation 16.6069
|
|
Mean Volume of ROI for Each Organ at All Time Points
Thigh muscle: PET scan 2; n=8
|
40.975 Milliliter (mL)
Standard Deviation 12.4102
|
|
Mean Volume of ROI for Each Organ at All Time Points
Thigh muscle: PET scan 3; n=7
|
40.094 Milliliter (mL)
Standard Deviation 6.7137
|
|
Mean Volume of ROI for Each Organ at All Time Points
Thigh muscle: PET scan 4; n=7
|
38.874 Milliliter (mL)
Standard Deviation 10.7444
|
|
Mean Volume of ROI for Each Organ at All Time Points
Liver: PET scan 1; n=8
|
574.546 Milliliter (mL)
Standard Deviation 301.4580
|
|
Mean Volume of ROI for Each Organ at All Time Points
Liver: PET scan 2; n=8
|
532.373 Milliliter (mL)
Standard Deviation 147.3186
|
|
Mean Volume of ROI for Each Organ at All Time Points
Liver: PET scan 3; n=7
|
488.974 Milliliter (mL)
Standard Deviation 156.2512
|
|
Mean Volume of ROI for Each Organ at All Time Points
Liver: PET scan 4; n=7
|
496.861 Milliliter (mL)
Standard Deviation 166.0174
|
|
Mean Volume of ROI for Each Organ at All Time Points
Pancreas: PET scan 1; n=7
|
7.777 Milliliter (mL)
Standard Deviation 3.3295
|
|
Mean Volume of ROI for Each Organ at All Time Points
Pancreas: PET scan 2; n=7
|
7.780 Milliliter (mL)
Standard Deviation 2.7156
|
|
Mean Volume of ROI for Each Organ at All Time Points
Pancreas: PET scan 3; n=6
|
5.905 Milliliter (mL)
Standard Deviation 3.0366
|
|
Mean Volume of ROI for Each Organ at All Time Points
Pancreas: PET scan 4; n=6
|
6.877 Milliliter (mL)
Standard Deviation 4.7283
|
|
Mean Volume of ROI for Each Organ at All Time Points
Thyroid gland: PET scan 1; n=8
|
2.750 Milliliter (mL)
Standard Deviation 1.5549
|
|
Mean Volume of ROI for Each Organ at All Time Points
Thyroid gland: PET scan 2; n=8
|
3.004 Milliliter (mL)
Standard Deviation 0.9845
|
|
Mean Volume of ROI for Each Organ at All Time Points
Thyroid gland: PET scan 3; n=7
|
2.913 Milliliter (mL)
Standard Deviation 0.9590
|
|
Mean Volume of ROI for Each Organ at All Time Points
Thyroid gland: PET scan 4; n=7
|
4.137 Milliliter (mL)
Standard Deviation 2.0853
|
|
Mean Volume of ROI for Each Organ at All Time Points
Testis: PET scan 1; n=8
|
13.223 Milliliter (mL)
Standard Deviation 6.7226
|
|
Mean Volume of ROI for Each Organ at All Time Points
Testis: PET scan 2; n=8
|
12.010 Milliliter (mL)
Standard Deviation 6.5955
|
|
Mean Volume of ROI for Each Organ at All Time Points
Testis: PET scan 3; n=7
|
11.583 Milliliter (mL)
Standard Deviation 4.5054
|
|
Mean Volume of ROI for Each Organ at All Time Points
Testis: PET scan 4; n=7
|
13.871 Milliliter (mL)
Standard Deviation 7.6413
|
|
Mean Volume of ROI for Each Organ at All Time Points
Bladder: PET scan 1; n=8
|
84.228 Milliliter (mL)
Standard Deviation 69.2024
|
|
Mean Volume of ROI for Each Organ at All Time Points
Bladder: PET scan 2; n=8
|
60.669 Milliliter (mL)
Standard Deviation 26.7843
|
|
Mean Volume of ROI for Each Organ at All Time Points
Bladder: PET scan 3; n=7
|
54.771 Milliliter (mL)
Standard Deviation 26.2373
|
|
Mean Volume of ROI for Each Organ at All Time Points
Bladder: PET scan 4; n=7
|
66.291 Milliliter (mL)
Standard Deviation 47.1061
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney: PET scan 1; n=8
|
144.093 Milliliter (mL)
Standard Deviation 32.8834
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney: PET scan 2; n=8
|
162.578 Milliliter (mL)
Standard Deviation 55.1273
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney: PET scan 3; n=7
|
152.031 Milliliter (mL)
Standard Deviation 36.5278
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney: PET scan 4; n=7
|
177.840 Milliliter (mL)
Standard Deviation 30.9614
|
|
Mean Volume of ROI for Each Organ at All Time Points
Parotid gland: PET scan 1; n=8
|
8.304 Milliliter (mL)
Standard Deviation 3.5772
|
|
Mean Volume of ROI for Each Organ at All Time Points
Parotid gland: PET scan 2; n=8
|
9.391 Milliliter (mL)
Standard Deviation 4.2224
|
|
Mean Volume of ROI for Each Organ at All Time Points
Parotid gland: PET scan 3; n=7
|
8.611 Milliliter (mL)
Standard Deviation 1.6606
|
|
Mean Volume of ROI for Each Organ at All Time Points
Parotid gland: PET scan 4; n=7
|
9.896 Milliliter (mL)
Standard Deviation 2.6622
|
|
Mean Volume of ROI for Each Organ at All Time Points
Bone marrow: PET scan 1; n=8
|
36.625 Milliliter (mL)
Standard Deviation 18.3824
|
|
Mean Volume of ROI for Each Organ at All Time Points
Bone marrow: PET scan 2; n=8
|
37.495 Milliliter (mL)
Standard Deviation 15.1968
|
|
Mean Volume of ROI for Each Organ at All Time Points
Bone marrow: PET scan 3; n=7
|
45.271 Milliliter (mL)
Standard Deviation 18.2245
|
|
Mean Volume of ROI for Each Organ at All Time Points
Bone marrow: PET scan 4; n=7
|
42.871 Milliliter (mL)
Standard Deviation 14.4365
|
|
Mean Volume of ROI for Each Organ at All Time Points
Spleen: PET scan 1; n=8
|
62.238 Milliliter (mL)
Standard Deviation 20.6549
|
|
Mean Volume of ROI for Each Organ at All Time Points
Spleen: PET scan 2; n=8
|
67.160 Milliliter (mL)
Standard Deviation 21.9034
|
|
Mean Volume of ROI for Each Organ at All Time Points
Spleen: PET scan 3; n=7
|
54.544 Milliliter (mL)
Standard Deviation 13.4153
|
|
Mean Volume of ROI for Each Organ at All Time Points
Spleen: PET scan 4; n=7
|
47.474 Milliliter (mL)
Standard Deviation 18.3678
|
|
Mean Volume of ROI for Each Organ at All Time Points
Brain: PET scan 1; n=8
|
575.996 Milliliter (mL)
Standard Deviation 91.2147
|
|
Mean Volume of ROI for Each Organ at All Time Points
Brain: PET scan 2; n=8
|
510.614 Milliliter (mL)
Standard Deviation 139.8124
|
|
Mean Volume of ROI for Each Organ at All Time Points
Brain: PET scan 3; n=7
|
471.550 Milliliter (mL)
Standard Deviation 152.8605
|
|
Mean Volume of ROI for Each Organ at All Time Points
Brain: PET scan 4; n=7
|
498.207 Milliliter (mL)
Standard Deviation 145.5429
|
|
Mean Volume of ROI for Each Organ at All Time Points
Lung: PET scan 1; n=8
|
329.891 Milliliter (mL)
Standard Deviation 134.1686
|
|
Mean Volume of ROI for Each Organ at All Time Points
Lung: PET scan 2; n=8
|
329.374 Milliliter (mL)
Standard Deviation 162.8302
|
|
Mean Volume of ROI for Each Organ at All Time Points
Lung: PET scan 3; n=7
|
328.794 Milliliter (mL)
Standard Deviation 115.2736
|
|
Mean Volume of ROI for Each Organ at All Time Points
Lung: PET scan 4; n=7
|
308.494 Milliliter (mL)
Standard Deviation 77.7344
|
|
Mean Volume of ROI for Each Organ at All Time Points
Aorta: PET scan 1; n=8
|
6.388 Milliliter (mL)
Standard Deviation 2.9532
|
|
Mean Volume of ROI for Each Organ at All Time Points
Aorta: PET scan 2; n=8
|
8.171 Milliliter (mL)
Standard Deviation 3.5471
|
|
Mean Volume of ROI for Each Organ at All Time Points
Aorta: PET scan 3; n=7
|
7.887 Milliliter (mL)
Standard Deviation 3.1780
|
|
Mean Volume of ROI for Each Organ at All Time Points
Aorta: PET scan 4; n=7
|
8.199 Milliliter (mL)
Standard Deviation 3.5405
|
|
Mean Volume of ROI for Each Organ at All Time Points
Heart: PET scan 1; n=8
|
135.013 Milliliter (mL)
Standard Deviation 74.5105
|
|
Mean Volume of ROI for Each Organ at All Time Points
Heart: PET scan 2; n=8
|
111.133 Milliliter (mL)
Standard Deviation 53.4101
|
|
Mean Volume of ROI for Each Organ at All Time Points
Heart: PET scan 3; n=7
|
105.007 Milliliter (mL)
Standard Deviation 26.1510
|
|
Mean Volume of ROI for Each Organ at All Time Points
Heart: PET scan 4; n=7
|
103.971 Milliliter (mL)
Standard Deviation 40.0218
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney, cortex: PET scan 1; n=8
|
5.483 Milliliter (mL)
Standard Deviation 3.0342
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney, cortex: PET scan 2; n=8
|
5.728 Milliliter (mL)
Standard Deviation 2.7257
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney, cortex: PET scan 4; n=7
|
7.229 Milliliter (mL)
Standard Deviation 3.5309
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney, medulla: PET scan 1; n=8
|
4.646 Milliliter (mL)
Standard Deviation 2.1984
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney, medulla: PET scan 2; n=8
|
4.885 Milliliter (mL)
Standard Deviation 2.3112
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney, medulla: PET scan 3; n=7
|
6.104 Milliliter (mL)
Standard Deviation 1.4927
|
|
Mean Volume of ROI for Each Organ at All Time Points
Kidney, medulla: PET scan 4; n=7
|
6.661 Milliliter (mL)
Standard Deviation 3.3183
|
|
Mean Volume of ROI for Each Organ at All Time Points
Body: PET scan 1; n=8
|
103654.675 Milliliter (mL)
Standard Deviation 29591.9710
|
|
Mean Volume of ROI for Each Organ at All Time Points
Body: PET scan 2; n=8
|
106925.973 Milliliter (mL)
Standard Deviation 32398.3328
|
|
Mean Volume of ROI for Each Organ at All Time Points
Body: PET scan 3; n=7
|
96034.243 Milliliter (mL)
Standard Deviation 22195.6206
|
|
Mean Volume of ROI for Each Organ at All Time Points
Body: PET scan 4; n=7
|
100291.249 Milliliter (mL)
Standard Deviation 27671.1649
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour (h), 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included AUC (0-t) and AUC (0-inf). AUC (0-t) and AUC (0-inf) for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. AUC (0-t) and AUC (0-inf) for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) and Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-inf]) of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: AUC (0-t)
|
461526.5722 (Becquerel [Bq] per mL)*h
Geometric Coefficient of Variation 11.1647
|
|
Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) and Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-inf]) of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: AUC (0-inf)
|
930260.1961 (Becquerel [Bq] per mL)*h
Geometric Coefficient of Variation 19.4399
|
|
Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) and Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-inf]) of 89Zr-GSK3128349 and GSK3128349
GSK3128349: AUC (0-t)
|
82177.6360 (Becquerel [Bq] per mL)*h
Geometric Coefficient of Variation 19.0961
|
|
Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) and Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-inf]) of 89Zr-GSK3128349 and GSK3128349
GSK3128349: AUC (0-inf)
|
104257.7700 (Becquerel [Bq] per mL)*h
Geometric Coefficient of Variation 16.5839
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included AUCex and AUMCex. AUCex and AUMCex for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. AUCex and AUMCex for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Percent Area Under the Curve Obtained by Extrapolation (AUCex) and Percent Area Under the First Moment Curve Obtained by Extrapolation (AUMCex) of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: Percent AUCex
|
48.5838 Percentage area under the curve
Geometric Coefficient of Variation 20.4243
|
|
Percent Area Under the Curve Obtained by Extrapolation (AUCex) and Percent Area Under the First Moment Curve Obtained by Extrapolation (AUMCex) of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: Percent AUMCex
|
84.0346 Percentage area under the curve
Geometric Coefficient of Variation 8.3187
|
|
Percent Area Under the Curve Obtained by Extrapolation (AUCex) and Percent Area Under the First Moment Curve Obtained by Extrapolation (AUMCex) of 89Zr-GSK3128349 and GSK3128349
GSK3128349: Percent AUCex
|
20.7353 Percentage area under the curve
Geometric Coefficient of Variation 19.8191
|
|
Percent Area Under the Curve Obtained by Extrapolation (AUCex) and Percent Area Under the First Moment Curve Obtained by Extrapolation (AUMCex) of 89Zr-GSK3128349 and GSK3128349
GSK3128349: Percent AUMCex
|
55.9698 Percentage area under the curve
Geometric Coefficient of Variation 11.6540
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included Cmax. Cmax for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of 89Zr-GSK3128349
|
3872.7027 Bq per mL
Geometric Coefficient of Variation 8.6104
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included Cmax. Cmax for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Cmax of GSK3128349
|
374.3868 Nanogram (ng) per mL
Geometric Coefficient of Variation 10.4183
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included t1/2 and MRT. t1/2 and MRT for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. t1/2 and MRT for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Apparent Terminal Phase Half-life (t1/2) and Mean Residence Time (MRT) of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: t1/2
|
279.3697 Hours
Geometric Coefficient of Variation 40.6517
|
|
Apparent Terminal Phase Half-life (t1/2) and Mean Residence Time (MRT) of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: MRT
|
404.8882 Hours
Geometric Coefficient of Variation 36.4904
|
|
Apparent Terminal Phase Half-life (t1/2) and Mean Residence Time (MRT) of 89Zr-GSK3128349 and GSK3128349
GSK3128349: t1/2
|
420.6105 Hours
Geometric Coefficient of Variation 9.2835
|
|
Apparent Terminal Phase Half-life (t1/2) and Mean Residence Time (MRT) of 89Zr-GSK3128349 and GSK3128349
GSK3128349: MRT
|
562.3356 Hours
Geometric Coefficient of Variation 9.7841
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included lambda-z. Cmax for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Elimination Rate Constant (Lambda-z) of 89Zr-GSK3128349
|
0.0025 1 per h
Geometric Coefficient of Variation 40.6517
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included Vss and Vz. Vss and Vz for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. Vss and Vz for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Volume of Distribution at a Steady State (Vss) and Volume of Distribution in the Terminal Phase (Vz) of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: Vss
|
5440.5241 mL
Geometric Coefficient of Variation 21.7532
|
|
Volume of Distribution at a Steady State (Vss) and Volume of Distribution in the Terminal Phase (Vz) of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: Vz
|
5415.7602 mL
Geometric Coefficient of Variation 25.5996
|
|
Volume of Distribution at a Steady State (Vss) and Volume of Distribution in the Terminal Phase (Vz) of 89Zr-GSK3128349 and GSK3128349
GSK3128349: Vss
|
5393.6763 mL
Geometric Coefficient of Variation 13.5175
|
|
Volume of Distribution at a Steady State (Vss) and Volume of Distribution in the Terminal Phase (Vz) of 89Zr-GSK3128349 and GSK3128349
GSK3128349: Vz
|
5820.3069 mL
Geometric Coefficient of Variation 13.9190
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included AUMC (0-inf) and AUMC (0-t). AUMC (0-inf) and AUMC (0-t) for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Area Under the First Moment Curve From Pre-dose Extrapolated to Infinite Time (AUMC [0-inf]) and Area Under the First Moment Curve From Pre-dose Extrapolated to Last Time of Quantifiable Concentration (AUMC [0-t]) of 89Zr-GSK3128349
89Zr-GSK3128349: AUMC (0-inf)
|
376651413.6839 (Bq/mL)*h^2)
Geometric Coefficient of Variation 56.6074
|
|
Area Under the First Moment Curve From Pre-dose Extrapolated to Infinite Time (AUMC [0-inf]) and Area Under the First Moment Curve From Pre-dose Extrapolated to Last Time of Quantifiable Concentration (AUMC [0-t]) of 89Zr-GSK3128349
89Zr-GSK3128349: AUMC (0-t)
|
53242134.4377 (Bq/mL)*h^2)
Geometric Coefficient of Variation 10.0977
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included AUMC (0-inf) and AUMC (0-t). AUMC (0-inf) and AUMC (0-t) for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
AUMC (0-inf) and AUMC (0-t) of GSK3128349
GSK3128349: AUMC (0-inf)
|
58627561.8533 (ng/mL)*h^2
Geometric Coefficient of Variation 23.8246
|
|
AUMC (0-inf) and AUMC (0-t) of GSK3128349
GSK3128349: AUMC (0-t)
|
25366300.3864 (ng/mL)*h^2
Geometric Coefficient of Variation 31.7095
|
SECONDARY outcome
Timeframe: Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45Population: PK Population. Only those participants available at the specified time points were analyzed.
PK parameters included clearance. Clearance for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. Clearance for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Clearance of 89Zr-GSK3128349 and GSK3128349
89Zr-GSK3128349: Clearance
|
13.4371 mL/h
Geometric Coefficient of Variation 19.4399
|
|
Clearance of 89Zr-GSK3128349 and GSK3128349
GSK3128349: Clearance
|
9.5918 mL/h
Geometric Coefficient of Variation 16.5657
|
SECONDARY outcome
Timeframe: Up to Day 7Population: PK Population. Only those participants available at the specified time points were analyzed.
Organ dose was defined as the amount of radiation delivered to a particular organ. Effective dose was defined as the tissue-weighted sum of the organ doses in all specified tissues and organs of the human body. The organ and effective dose is a fraction of milliSievert (mSv) and MegaBecquerel (MBq). The mean relative uptake of 89Zr-GSK3128349 in different organs for all participants across all PET scans is presented.
Outcome measures
| Measure |
89Zr-GSK3128349
n=7 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Mean Organ and Effective Dose
Thymus gland
|
0.3457 mSv/MBq
Standard Deviation 0.03229
|
|
Mean Organ and Effective Dose
Liver
|
0.7909 mSv/MBq
Standard Deviation 0.15549
|
|
Mean Organ and Effective Dose
Pancreas
|
0.5701 mSv/MBq
Standard Deviation 0.09391
|
|
Mean Organ and Effective Dose
Thyroid gland
|
0.4004 mSv/MBq
Standard Deviation 0.09722
|
|
Mean Organ and Effective Dose
Testis
|
0.4827 mSv/MBq
Standard Deviation 0.03345
|
|
Mean Organ and Effective Dose
Bladder
|
0.2889 mSv/MBq
Standard Deviation 0.02315
|
|
Mean Organ and Effective Dose
Kidney
|
1.3871 mSv/MBq
Standard Deviation 0.30625
|
|
Mean Organ and Effective Dose
Bone marrow
|
0.3407 mSv/MBq
Standard Deviation 0.03146
|
|
Mean Organ and Effective Dose
Spleen
|
0.7314 mSv/MBq
Standard Deviation 0.08562
|
|
Mean Organ and Effective Dose
Brain
|
0.1431 mSv/MBq
Standard Deviation 0.04001
|
|
Mean Organ and Effective Dose
Lung
|
0.8413 mSv/MBq
Standard Deviation 0.17595
|
|
Mean Organ and Effective Dose
Heart
|
0.6721 mSv/MBq
Standard Deviation 0.14849
|
|
Mean Organ and Effective Dose
Body
|
0.4480 mSv/MBq
Standard Deviation 0.03811
|
SECONDARY outcome
Timeframe: Up to 45 daysPopulation: Safety Population which comprised of all participants who received a dose of 89Zr-GSK3128349.
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or is associated with liver injury or impaired liver function.
Outcome measures
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE
|
2 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
SAE
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 45 daysPopulation: Safety Population.
The potential clinical concern range for clinical chemistry parameters were: glucose (low: \< 3 millimole \[mmol\]/L and high: \> 9 mmol/L), creatinine (high: Change from Baseline or Day 1 should be positive and \> 44.2 mmol/L), phosphorous (low: \< 0.8 mmol/L and high: \> 1.6 mmol/L), magnesium (low: \< 0.5 mmol/L and high: \> 1.23 mmol/L), calcium (low: \<2 mmoL/L and high: \> 2.75 mmol/L), carbon dioxide content (low: \< 18 mmol/L and high: \> 32 mmol/L), albumin (low: \< 30 mmol/L), potassium (low: \< 3.0 mmol/L and high: \> 5.5 mmol/L) and sodium (low: \< 130 mmol/L and high: \> 130 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented
Outcome measures
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Number of Participants With Clinical Chemistry Data of Potential Clinical Concern
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 45 daysPopulation: Safety Population.
The potential clinical concern range for hematology parameters were: Hemoglobin (low: \> 25 gram per Liter change from Baseline/Day 1 and high: \> 180 gram per Liter), lymphocytes (low: \< 0.8 gigacells/L), hematocrit (low: \> 0.075 ratio change from Baseline and high: \> 0.54 ratio), neutrophil count (low: \< 1.5\*10\^9/Liter), platelet count (low: \< 100 gigacells/L and high: \> 550 gigacells/L), white blood cell (WBC) count (low: \< 3 gigacells/L and high: \> 20 gigacells/L). Number of participants with hematology abnormalities of potential clinical importance are presented.
Outcome measures
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Number of Participants With Hematology Data of Potential Clinical Concern
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, 1 h and 24 h post-dose on Day 1 and Day 45Population: Safety Population.
ECG measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before each reading. Triplicate 12-lead ECGS were obtained pre dose at Day 1 and single 12-lead ECGs will be obtained at other time points during the study. The potential clinical concern range for ECG parameters was as follows: Absolute corrected QT (QTc) interval (lower: \>450 milliseconds \[msec\], \>450 msec, \>=480 msec and \>=500 msec) and (higher: \<=479 msec and \<=499 msec); absolute PR interval (lower: \<110 and higher \>220 msec) and absolute QRS interval (lower: \<75 msec and \>110 msec). Number of participants with ECG values of potential clinical concern are presented.
Outcome measures
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
QRS duration
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
Heart rate
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
PR interval
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
RR interval
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
QT interval
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
QT interval corrected by Bazett's formula
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
QT interval corrected by Fridericia formula
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 45 daysPopulation: Safety Population.
Vital signs included pulse rate, systolic and diastolic blood pressure and body temperature. All vital sign measurements were made with the participant in a supine position and rested in this position for at least 5 minutes before each reading. The potential clinical concern range for systolic blood pressure: \<85 and \>160 millimeters of mercury (mmHg), for diastolic: \<45 and \>100 mmHg and heart rate: \<40 and \>110 beats per minute. Number of participants with vital signs of potential clinical concern are presented.
Outcome measures
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Concern
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and Day 43Population: Safety Population.
Blood samples for testing antibodies against GSK3128349 will be collected on Day 1 (pre-dose) and on Day 43. The actual date and time of each blood sample collection was recorded. The first blood sample was taken pre-dose on Day 1 to determine the presence, if any, of pre-existing Anti Drug Antibodies (ADAs). The presence of such antibodies was assessed using an electrochemiluminescent (ECL) immuno assay. If sera contain anti-GSK3128349 antibodies, they were further analyzed for the antibody specificity and titres. Number of participants who were found to have anti-GSK3128349 antibodies are presented.
Outcome measures
| Measure |
89Zr-GSK3128349
n=8 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Number of Participants With Positive Anti-GSK3128349 Antibody Assay
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and Day 43Population: Safety Population. Only those participants with positive anti-GSK3128349 antibody assay were analyzed.
Blood samples for testing antibodies against GSK3128349 will be collected on Day 1 (pre-dose) and on Day 43. The actual date and time of each blood sample collection was recorded. The first blood sample was taken pre-dose on Day 1 to determine the presence, if any, of pre-existing ADAs. The presence of such antibodies and serum titers of anti-GSK3128349 antibodies was assessed using an ECL immuno-assay. If sera contain anti-GSK3128349 antibodies, they were further analyzed for the antibody specificity and titers.
Outcome measures
| Measure |
89Zr-GSK3128349
n=1 Participants
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Serum Titers of Anti-GSK3128349 Antibodies
Day 1, pre-dose
|
80 Titers
Standard Deviation NA
NA indicates Not Available because single participant was analyzed so Standard deviation could not be derived.
|
|
Serum Titers of Anti-GSK3128349 Antibodies
Day 43
|
40 Titers
Standard Deviation NA
NA indicates Not Available because single participant was analyzed so Standard deviation could not be derived.
|
Adverse Events
89Zr-GSK3128349
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
89Zr-GSK3128349
n=8 participants at risk
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
|
|---|---|
|
Infections and infestations
Influenza
|
12.5%
1/8 • Up to 45 days
SAE and non-SAE are reported for the Safety Population which comprised of all participants who received a dose of 89Zr-GSK3128349.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Up to 45 days
SAE and non-SAE are reported for the Safety Population which comprised of all participants who received a dose of 89Zr-GSK3128349.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Up to 45 days
SAE and non-SAE are reported for the Safety Population which comprised of all participants who received a dose of 89Zr-GSK3128349.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER