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Trial record 78 of 119 for:    ZIRCONIUM

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02829307
Recruitment Status : Completed
First Posted : July 12, 2016
Results First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
PRA Health Sciences for clinical study conduct.
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Drug-Related Side Effects and Adverse Reactions
Intervention Drug: 89Zr-GSK3128349 1 mg
Enrollment 8
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 milligram (mg).
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
Safety Population comprised of all participants who received a dose of GSK3128349 radiolabelled with 89-zirconium (89Zr-GSK3128349).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
55.0  (2.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
0
   0.0%
Male
8
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaskan Native
1
  12.5%
White- White/Caucasian/ European Heritage
7
  87.5%
1.Primary Outcome
Title Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data
Hide Description 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.
Time Frame Up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Ratio
Thigh muscle: PET scan 1; n=8 Number Analyzed 8 participants
0.515  (0.1387)
Thigh muscle: PET scan 2; n=8 Number Analyzed 8 participants
0.566  (0.1315)
Thigh muscle: PET scan 3; n=7 Number Analyzed 7 participants
0.607  (0.0767)
Thigh muscle: PET scan 4; n=7 Number Analyzed 7 participants
0.623  (0.1509)
Liver: PET scan 1; n=8 Number Analyzed 8 participants
4.929  (0.7219)
Liver: PET scan 2; n=8 Number Analyzed 8 participants
3.231  (0.4981)
Liver: PET scan 3; n=7 Number Analyzed 7 participants
2.994  (0.7314)
Liver: PET scan 4; n=7 Number Analyzed 7 participants
2.280  (0.3151)
Pancreas: PET scan 1; n=7 Number Analyzed 7 participants
2.177  (0.4573)
Pancreas: PET scan 2; n=7 Number Analyzed 7 participants
2.029  (0.6621)
Pancreas: PET scan 3; n=6 Number Analyzed 6 participants
1.887  (0.4131)
Pancreas: PET scan 4; n=6 Number Analyzed 6 participants
1.917  (1.0314)
Thyroid gland: PET scan 1; n=8 Number Analyzed 8 participants
2.338  (0.8821)
Thyroid gland: PET scan 2; n=8 Number Analyzed 8 participants
2.171  (0.8408)
Thyroid gland: PET scan 3; n=7 Number Analyzed 7 participants
2.330  (1.0510)
Thyroid gland: PET scan 4; n=7 Number Analyzed 7 participants
1.789  (0.4791)
Testis: PET scan 1; n=8 Number Analyzed 8 participants
3.336  (0.7479)
Testis: PET scan 2; n=8 Number Analyzed 8 participants
3.733  (0.7793)
Testis: PET scan 3; n=7 Number Analyzed 7 participants
3.259  (0.9988)
Testis: PET scan 4; n=7 Number Analyzed 7 participants
3.280  (0.4789)
Bladder: PET scan 1; n=8 Number Analyzed 8 participants
2.750  (1.0483)
Bladder: PET scan 2; n=8 Number Analyzed 8 participants
1.149  (0.4572)
Bladder: PET scan 3; n=7 Number Analyzed 7 participants
1.630  (0.4938)
Bladder: PET scan 4; n=7 Number Analyzed 7 participants
1.609  (0.4176)
Kidney: PET scan 1; n=8 Number Analyzed 8 participants
7.845  (1.1487)
Kidney: PET scan 2; n=8 Number Analyzed 8 participants
9.516  (1.0005)
Kidney: PET scan 3; n=7 Number Analyzed 7 participants
10.466  (2.2765)
Kidney: PET scan 4; n=7 Number Analyzed 7 participants
8.603  (1.6626)
Parotid gland: PET scan 1; n=8 Number Analyzed 8 participants
1.514  (0.3005)
Parotid gland: PET scan 2; n=8 Number Analyzed 8 participants
1.430  (0.3091)
Parotid gland: PET scan 3; n=7 Number Analyzed 7 participants
1.541  (0.2084)
Parotid gland: PET scan 4; n=7 Number Analyzed 7 participants
1.531  (0.1643)
Bone marrow: PET scan 1; n=8 Number Analyzed 8 participants
1.746  (0.2575)
Bone marrow: PET scan 2; n=8 Number Analyzed 8 participants
1.378  (0.2066)
Bone marrow: PET scan 3; n=7 Number Analyzed 7 participants
1.289  (0.2998)
Bone marrow: PET scan 4; n=7 Number Analyzed 7 participants
1.350  (0.2802)
Spleen: PET scan 1; n=8 Number Analyzed 8 participants
5.220  (0.6398)
Spleen: PET scan 2; n=8 Number Analyzed 8 participants
3.691  (0.4638)
Spleen: PET scan 3; n=7 Number Analyzed 7 participants
3.296  (0.8611)
Spleen: PET scan 4; n=7 Number Analyzed 7 participants
3.097  (0.4946)
Brain: PET scan 1; n=8 Number Analyzed 8 participants
0.461  (0.0762)
Brain: PET scan 2; n=8 Number Analyzed 8 participants
0.295  (0.0901)
Brain: PET scan 3; n=7 Number Analyzed 7 participants
0.231  (0.0689)
Brain: PET scan 4; n=7 Number Analyzed 7 participants
0.201  (0.0348)
Lung: PET scan 1; n=8 Number Analyzed 8 participants
1.884  (0.5968)
Lung: PET scan 2; n=8 Number Analyzed 8 participants
1.345  (0.4381)
Lung: PET scan 3; n=7 Number Analyzed 7 participants
1.186  (0.4720)
Lung: PET scan 4; n=7 Number Analyzed 7 participants
0.893  (0.2583)
Aorta: PET scan 1; n=8 Number Analyzed 8 participants
10.835  (2.0289)
Aorta: PET scan 2; n=8 Number Analyzed 8 participants
6.573  (1.5621)
Aorta: PET scan 3; n=7 Number Analyzed 7 participants
5.516  (1.4879)
Aorta: PET scan 4; n=7 Number Analyzed 7 participants
4.299  (0.8195)
Heart: PET scan 1; n=8 Number Analyzed 8 participants
8.601  (1.8566)
Heart: PET scan 2; n=8 Number Analyzed 8 participants
5.851  (1.5742)
Heart: PET scan 3; n=7 Number Analyzed 7 participants
4.829  (1.3661)
Heart: PET scan 4; n=7 Number Analyzed 7 participants
3.701  (0.6770)
Kidney, cortex: PET scan 1; n=8 Number Analyzed 8 participants
8.805  (1.4835)
Kidney, cortex: PET scan 2; n=8 Number Analyzed 8 participants
12.145  (1.7704)
Kidney, cortex: PET scan 3; n=7 Number Analyzed 7 participants
11.966  (1.5492)
Kidney, cortex: PET scan 4; n=7 Number Analyzed 7 participants
10.479  (1.6047)
Kidney, medulla: PET scan 1; n=8 Number Analyzed 8 participants
6.996  (1.5577)
Kidney, medulla: PET scan 2; n=8 Number Analyzed 8 participants
7.416  (1.2101)
Kidney, medulla: PET scan 3; n=7 Number Analyzed 7 participants
8.247  (2.3436)
Kidney, medulla: PET scan 4; n=7 Number Analyzed 7 participants
6.691  (1.1767)
Body: PET scan 1; n=8 Number Analyzed 8 participants
0.739  (0.1647)
Body: PET scan 2; n=8 Number Analyzed 8 participants
0.654  (0.1632)
Body: PET scan 3; n=7 Number Analyzed 7 participants
0.701  (0.1728)
Body: PET scan 4; n=7 Number Analyzed 7 participants
0.631  (0.1680)
2.Primary Outcome
Title Mean Volume of ROI for Each Organ at All Time Points
Hide Description 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.
Time Frame Up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Milliliter (mL)
Thigh muscle: PET scan 1; n=8 Number Analyzed 8 participants
45.001  (16.6069)
Thigh muscle: PET scan 2; n=8 Number Analyzed 8 participants
40.975  (12.4102)
Thigh muscle: PET scan 3; n=7 Number Analyzed 7 participants
40.094  (6.7137)
Thigh muscle: PET scan 4; n=7 Number Analyzed 7 participants
38.874  (10.7444)
Liver: PET scan 1; n=8 Number Analyzed 8 participants
574.546  (301.4580)
Liver: PET scan 2; n=8 Number Analyzed 8 participants
532.373  (147.3186)
Liver: PET scan 3; n=7 Number Analyzed 7 participants
488.974  (156.2512)
Liver: PET scan 4; n=7 Number Analyzed 7 participants
496.861  (166.0174)
Pancreas: PET scan 1; n=7 Number Analyzed 7 participants
7.777  (3.3295)
Pancreas: PET scan 2; n=7 Number Analyzed 7 participants
7.780  (2.7156)
Pancreas: PET scan 3; n=6 Number Analyzed 6 participants
5.905  (3.0366)
Pancreas: PET scan 4; n=6 Number Analyzed 6 participants
6.877  (4.7283)
Thyroid gland: PET scan 1; n=8 Number Analyzed 8 participants
2.750  (1.5549)
Thyroid gland: PET scan 2; n=8 Number Analyzed 8 participants
3.004  (0.9845)
Thyroid gland: PET scan 3; n=7 Number Analyzed 7 participants
2.913  (0.9590)
Thyroid gland: PET scan 4; n=7 Number Analyzed 7 participants
4.137  (2.0853)
Testis: PET scan 1; n=8 Number Analyzed 8 participants
13.223  (6.7226)
Testis: PET scan 2; n=8 Number Analyzed 8 participants
12.010  (6.5955)
Testis: PET scan 3; n=7 Number Analyzed 7 participants
11.583  (4.5054)
Testis: PET scan 4; n=7 Number Analyzed 7 participants
13.871  (7.6413)
Bladder: PET scan 1; n=8 Number Analyzed 8 participants
84.228  (69.2024)
Bladder: PET scan 2; n=8 Number Analyzed 8 participants
60.669  (26.7843)
Bladder: PET scan 3; n=7 Number Analyzed 7 participants
54.771  (26.2373)
Bladder: PET scan 4; n=7 Number Analyzed 7 participants
66.291  (47.1061)
Kidney: PET scan 1; n=8 Number Analyzed 8 participants
144.093  (32.8834)
Kidney: PET scan 2; n=8 Number Analyzed 8 participants
162.578  (55.1273)
Kidney: PET scan 3; n=7 Number Analyzed 7 participants
152.031  (36.5278)
Kidney: PET scan 4; n=7 Number Analyzed 7 participants
177.840  (30.9614)
Parotid gland: PET scan 1; n=8 Number Analyzed 8 participants
8.304  (3.5772)
Parotid gland: PET scan 2; n=8 Number Analyzed 8 participants
9.391  (4.2224)
Parotid gland: PET scan 3; n=7 Number Analyzed 7 participants
8.611  (1.6606)
Parotid gland: PET scan 4; n=7 Number Analyzed 7 participants
9.896  (2.6622)
Bone marrow: PET scan 1; n=8 Number Analyzed 8 participants
36.625  (18.3824)
Bone marrow: PET scan 2; n=8 Number Analyzed 8 participants
37.495  (15.1968)
Bone marrow: PET scan 3; n=7 Number Analyzed 7 participants
45.271  (18.2245)
Bone marrow: PET scan 4; n=7 Number Analyzed 7 participants
42.871  (14.4365)
Spleen: PET scan 1; n=8 Number Analyzed 8 participants
62.238  (20.6549)
Spleen: PET scan 2; n=8 Number Analyzed 8 participants
67.160  (21.9034)
Spleen: PET scan 3; n=7 Number Analyzed 7 participants
54.544  (13.4153)
Spleen: PET scan 4; n=7 Number Analyzed 7 participants
47.474  (18.3678)
Brain: PET scan 1; n=8 Number Analyzed 8 participants
575.996  (91.2147)
Brain: PET scan 2; n=8 Number Analyzed 8 participants
510.614  (139.8124)
Brain: PET scan 3; n=7 Number Analyzed 7 participants
471.550  (152.8605)
Brain: PET scan 4; n=7 Number Analyzed 7 participants
498.207  (145.5429)
Lung: PET scan 1; n=8 Number Analyzed 8 participants
329.891  (134.1686)
Lung: PET scan 2; n=8 Number Analyzed 8 participants
329.374  (162.8302)
Lung: PET scan 3; n=7 Number Analyzed 7 participants
328.794  (115.2736)
Lung: PET scan 4; n=7 Number Analyzed 7 participants
308.494  (77.7344)
Aorta: PET scan 1; n=8 Number Analyzed 8 participants
6.388  (2.9532)
Aorta: PET scan 2; n=8 Number Analyzed 8 participants
8.171  (3.5471)
Aorta: PET scan 3; n=7 Number Analyzed 7 participants
7.887  (3.1780)
Aorta: PET scan 4; n=7 Number Analyzed 7 participants
8.199  (3.5405)
Heart: PET scan 1; n=8 Number Analyzed 8 participants
135.013  (74.5105)
Heart: PET scan 2; n=8 Number Analyzed 8 participants
111.133  (53.4101)
Heart: PET scan 3; n=7 Number Analyzed 7 participants
105.007  (26.1510)
Heart: PET scan 4; n=7 Number Analyzed 7 participants
103.971  (40.0218)
Kidney, cortex: PET scan 1; n=8 Number Analyzed 8 participants
5.483  (3.0342)
Kidney, cortex: PET scan 2; n=8 Number Analyzed 8 participants
5.728  (2.7257)
Kidney, cortex: PET scan 3; n=7 Number Analyzed 7 participants
6.770  (1.2609)
Kidney, cortex: PET scan 4; n=7 Number Analyzed 7 participants
7.229  (3.5309)
Kidney, medulla: PET scan 1; n=8 Number Analyzed 8 participants
4.646  (2.1984)
Kidney, medulla: PET scan 2; n=8 Number Analyzed 8 participants
4.885  (2.3112)
Kidney, medulla: PET scan 3; n=7 Number Analyzed 7 participants
6.104  (1.4927)
Kidney, medulla: PET scan 4; n=7 Number Analyzed 7 participants
6.661  (3.3183)
Body: PET scan 1; n=8 Number Analyzed 8 participants
103654.675  (29591.9710)
Body: PET scan 2; n=8 Number Analyzed 8 participants
106925.973  (32398.3328)
Body: PET scan 3; n=7 Number Analyzed 7 participants
96034.243  (22195.6206)
Body: PET scan 4; n=7 Number Analyzed 7 participants
100291.249  (27671.1649)
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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 45
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (Becquerel [Bq] per mL)*h
89Zr-GSK3128349: AUC (0-t)
461526.5722
(11.1647%)
89Zr-GSK3128349: AUC (0-inf)
930260.1961
(19.4399%)
GSK3128349: AUC (0-t)
82177.6360
(19.0961%)
GSK3128349: AUC (0-inf)
104257.7700
(16.5839%)
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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 45
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage area under the curve
89Zr-GSK3128349: Percent AUCex
48.5838
(20.4243%)
89Zr-GSK3128349: Percent AUMCex
84.0346
(8.3187%)
GSK3128349: Percent AUCex
20.7353
(19.8191%)
GSK3128349: Percent AUMCex
55.9698
(11.6540%)
5.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of 89Zr-GSK3128349
Hide Description PK parameters included Cmax. Cmax for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting.
Time Frame 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 45
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Bq per mL
3872.7027
(8.6104%)
6.Secondary Outcome
Title Cmax of GSK3128349
Hide Description PK parameters included Cmax. Cmax for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.
Time Frame 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 45
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram (ng) per mL
374.3868
(10.4183%)
7.Secondary Outcome
Title Apparent Terminal Phase Half-life (t1/2) and Mean Residence Time (MRT) of 89Zr-GSK3128349 and GSK3128349
Hide Description 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.
Time Frame 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 45
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
89Zr-GSK3128349: t1/2
279.3697
(40.6517%)
89Zr-GSK3128349: MRT
404.8882
(36.4904%)
GSK3128349: t1/2
420.6105
(9.2835%)
GSK3128349: MRT
562.3356
(9.7841%)
8.Secondary Outcome
Title Elimination Rate Constant (Lambda-z) of 89Zr-GSK3128349
Hide Description PK parameters included lambda-z. Cmax for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting.
Time Frame 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 45
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1 per h
0.0025
(40.6517%)
9.Secondary Outcome
Title Volume of Distribution at a Steady State (Vss) and Volume of Distribution in the Terminal Phase (Vz) of 89Zr-GSK3128349 and GSK3128349
Hide Description 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.
Time Frame 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 45
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL
89Zr-GSK3128349: Vss
5440.5241
(21.7532%)
89Zr-GSK3128349: Vz
5415.7602
(25.5996%)
GSK3128349: Vss
5393.6763
(13.5175%)
GSK3128349: Vz
5820.3069
(13.9190%)
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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 45
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (Bq/mL)*h^2)
89Zr-GSK3128349: AUMC (0-inf)
376651413.6839
(56.6074%)
89Zr-GSK3128349: AUMC (0-t)
53242134.4377
(10.0977%)
11.Secondary Outcome
Title AUMC (0-inf) and AUMC (0-t) of GSK3128349
Hide Description 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.
Time Frame 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 45
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PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (ng/mL)*h^2
GSK3128349: AUMC (0-inf)
58627561.8533
(23.8246%)
GSK3128349: AUMC (0-t)
25366300.3864
(31.7095%)
12.Secondary Outcome
Title Clearance of 89Zr-GSK3128349 and GSK3128349
Hide Description 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.
Time Frame 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 45
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Hide Analysis Population Description
PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/h
89Zr-GSK3128349: Clearance
13.4371
(19.4399%)
GSK3128349: Clearance
9.5918
(16.5657%)
13.Secondary Outcome
Title Mean Organ and Effective Dose
Hide Description 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.
Time Frame Up to Day 7
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PK Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: mSv/MBq
Liver 0.7909  (0.15549)
Pancreas 0.5701  (0.09391)
Thyroid gland 0.4004  (0.09722)
Testis 0.4827  (0.03345)
Bladder 0.2889  (0.02315)
Kidney 1.3871  (0.30625)
Bone marrow 0.3407  (0.03146)
Spleen 0.7314  (0.08562)
Thymus gland 0.3457  (0.03229)
Brain 0.1431  (0.04001)
Lung 0.8413  (0.17595)
Heart 0.6721  (0.14849)
Body 0.4480  (0.03811)
14.Secondary Outcome
Title Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description 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.
Time Frame Up to 45 days
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Safety Population which comprised of all participants who received a dose of 89Zr-GSK3128349.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
AE 2
SAE 0
15.Secondary Outcome
Title Number of Participants With Clinical Chemistry Data of Potential Clinical Concern
Hide Description 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
Time Frame Up to 45 days
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Safety Population.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
0
16.Secondary Outcome
Title Number of Participants With Hematology Data of Potential Clinical Concern
Hide Description 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.
Time Frame Up to 45 days
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Safety Population.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
0
17.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
Hide Description 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.
Time Frame Pre-dose on Day 1, 1 h and 24 h post-dose on Day 1 and Day 45
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Safety Population.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
QRS duration 1
Heart rate 0
PR interval 0
RR interval 0
QT interval 0
QT interval corrected by Bazett's formula 0
QT interval corrected by Fridericia formula 0
18.Secondary Outcome
Title Number of Participants With Vital Signs of Potential Clinical Concern
Hide Description 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.
Time Frame Up to 45 days
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Safety Population.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
19.Secondary Outcome
Title Number of Participants With Positive Anti-GSK3128349 Antibody Assay
Hide Description 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.
Time Frame Pre-dose on Day 1 and Day 43
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Safety Population.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
1
20.Secondary Outcome
Title Serum Titers of Anti-GSK3128349 Antibodies
Hide Description 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.
Time Frame Pre-dose on Day 1 and Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with positive anti-GSK3128349 antibody assay were analyzed.
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description:
Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Titers
Day 1, pre-dose 80 [1]   (NA)
Day 43 40 [1]   (NA)
[1]
NA indicates Not Available because single participant was analyzed so Standard deviation could not be derived.
Time Frame Up to 45 days
Adverse Event Reporting Description SAE and non-SAE are reported for the Safety Population which comprised of all participants who received a dose of 89Zr-GSK3128349.
 
Arm/Group Title 89Zr-GSK3128349
Hide Arm/Group Description Eligible participants received a single dose of 89Zr-GSK3128349 as an IV infusion over 20 minutes to deliver a dose of 1 mg.
All-Cause Mortality
89Zr-GSK3128349
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
89Zr-GSK3128349
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
89Zr-GSK3128349
Affected / at Risk (%)
Total   2/8 (25.00%) 
Gastrointestinal disorders   
Flatulence  1  1/8 (12.50%) 
Infections and infestations   
Influenza  1  1/8 (12.50%) 
Nasopharyngitis  1  1/8 (12.50%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02829307     History of Changes
Other Study ID Numbers: 117169
First Submitted: July 8, 2016
First Posted: July 12, 2016
Results First Submitted: January 12, 2018
Results First Posted: September 7, 2018
Last Update Posted: September 7, 2018