Trial Outcomes & Findings for A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants (NCT NCT04394845)
NCT ID: NCT04394845
Last Updated: 2021-11-03
Results Overview
Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
Day 1
Results posted on
2021-11-03
Participant Flow
Screening assessments were completed within 30 days of Day 1.
Participant milestones
| Measure |
[18F]GTP1
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants
Baseline characteristics by cohort
| Measure |
[18F]GTP1
n=6 Participants
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
51.33 Years
STANDARD_DEVIATION 15.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight
|
55.32 Kg
STANDARD_DEVIATION 11.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: One participant was excluded from the analysis at mean collect times: 16.38604 and 32.41194 minutes due to power surge during the scan that caused the system to power off. The process to restart took \~20 min and the absence of these specific data points. There was no impact on the quality of the subsequent data.
Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).
Outcome measures
| Measure |
[18F]GTP1
n=6 Participants
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
[18F]GTP1 Male
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
|---|---|---|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 5.32767 minutes
|
0.33530 Percentage of Injected Dose
Standard Deviation 0.18795
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 16.38604 minutes
|
0.59398 Percentage of Injected Dose
Standard Deviation 0.11540
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 32.41194 minutes
|
2.13730 Percentage of Injected Dose
Standard Deviation 0.76985
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 53.21428 minutes
|
4.89330 Percentage of Injected Dose
Standard Deviation 1.41690
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 78.27645 minutes
|
9.38103 Percentage of Injected Dose
Standard Deviation 3.07024
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 97.78638 minutes
|
12.93725 Percentage of Injected Dose
Standard Deviation 4.91340
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 144.06733 minutes
|
20.76320 Percentage of Injected Dose
Standard Deviation 5.05449
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 187.27612 minutes
|
25.22968 Percentage of Injected Dose
Standard Deviation 6.09050
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 213.49112 minutes
|
29.06417 Percentage of Injected Dose
Standard Deviation 9.29250
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 258.12780 minutes
|
34.50070 Percentage of Injected Dose
Standard Deviation 9.38550
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 304.21875 minutes
|
36.95242 Percentage of Injected Dose
Standard Deviation 10.99721
|
—
|
|
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Mean collect time: 337.49112 minutes
|
39.75663 Percentage of Injected Dose
Standard Deviation 10.21783
|
—
|
PRIMARY outcome
Timeframe: Day 1Source organ uptake and washout with calculation of total number of disintegrations (or residence time, or kinetic values) using the area under the time-activity curve divided by the injected dose of radiopharmaceutical
Outcome measures
| Measure |
[18F]GTP1
n=3 Participants
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
[18F]GTP1 Male
n=3 Participants
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
|---|---|---|
|
Source Organ Residence Time (Total Number of Disintegrations)
Gallbladder Contents
|
0.0254 MBq x hour/MBq
Standard Deviation 0.038
|
0.0304 MBq x hour/MBq
Standard Deviation 0.023
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Gallbladder Contents with GB emptying model
|
0.0102 MBq x hour/MBq
Standard Deviation 0.012
|
0.0122 MBq x hour/MBq
Standard Deviation 0.00637
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Heart Wall
|
0.0153 MBq x hour/MBq
Standard Deviation 0.00326
|
0.019 MBq x hour/MBq
Standard Deviation 0.00774
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Kidneys
|
0.046 MBq x hour/MBq
Standard Deviation 0.0195
|
0.0448 MBq x hour/MBq
Standard Deviation 0.0114
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Brain
|
0.0375 MBq x hour/MBq
Standard Deviation 0.00295
|
0.0315 MBq x hour/MBq
Standard Deviation 0.00717
|
|
Source Organ Residence Time (Total Number of Disintegrations)
LLI Cont.
|
0.0416 MBq x hour/MBq
Standard Deviation 0.00214
|
0.0396 MBq x hour/MBq
Standard Deviation 0.00401
|
|
Source Organ Residence Time (Total Number of Disintegrations)
SI Cont.
|
0.415 MBq x hour/MBq
Standard Deviation 0.0219
|
0.395 MBq x hour/MBq
Standard Deviation 0.0397
|
|
Source Organ Residence Time (Total Number of Disintegrations)
ULI Cont.
|
0.228 MBq x hour/MBq
Standard Deviation 0.0117
|
0.217 MBq x hour/MBq
Standard Deviation 0.0219
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Liver
|
0.591 MBq x hour/MBq
Standard Deviation 0.112
|
0.532 MBq x hour/MBq
Standard Deviation 0.0284
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Lungs
|
0.0346 MBq x hour/MBq
Standard Deviation 0.00205
|
0.0523 MBq x hour/MBq
Standard Deviation 0.0125
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Spleen
|
0.00634 MBq x hour/MBq
Standard Deviation 0.00203
|
0.0074 MBq x hour/MBq
Standard Deviation 0.00339
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Urinary Bladder Contents
|
0.135 MBq x hour/MBq
Standard Deviation 0.047
|
0.237 MBq x hour/MBq
Standard Deviation 0.0332
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Urinary Bladder Contents with UB voiding model
|
0.18 MBq x hour/MBq
Standard Deviation 0.0717
|
0.222 MBq x hour/MBq
Standard Deviation 0.0441
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Remainder
|
0.743 MBq x hour/MBq
Standard Deviation 0.143
|
0.687 MBq x hour/MBq
Standard Deviation 0.056
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Remainder with UB voiding model
|
0.708 MBq x hour/MBq
Standard Deviation 0.181
|
0.675 MBq x hour/MBq
Standard Deviation 0.127
|
|
Source Organ Residence Time (Total Number of Disintegrations)
Remainder with both UB voiding and GB emptying models
|
0.723 MBq x hour/MBq
Standard Deviation 0.161
|
0.693 MBq x hour/MBq
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: Day 1Population: Testes not analyzed for female population.
Radiation absorbed dose estimates based on the Medical Internal Radiation Dose (MIRD) methodology utilizing urine data and International Commission on Radiological Protection (ICRP) gastrointestinal (GI) tract kinetics
Outcome measures
| Measure |
[18F]GTP1
n=3 Participants
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
[18F]GTP1 Male
n=3 Participants
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
|---|---|---|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Adrenals
|
0.0164 mSv/MBq
Standard Deviation 0.00156
|
0.0123 mSv/MBq
Standard Deviation 0.000451
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Heart Wall
|
0.0196 mSv/MBq
Standard Deviation 0.00309
|
0.0167 mSv/MBq
Standard Deviation 0.00439
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Ovaries
|
0.0276 mSv/MBq
Standard Deviation 0.00133
|
0.0216 mSv/MBq
Standard Deviation 0.00379
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Osteogenic Cells
|
0.0107 mSv/MBq
Standard Deviation 0.00161
|
0.00787 mSv/MBq
Standard Deviation 0.000946
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Skin
|
0.0055 mSv/MBq
Standard Deviation 0.000749
|
0.00428 mSv/MBq
Standard Deviation 0.000441
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Spleen
|
0.0156 mSv/MBq
Standard Deviation 0.00253
|
0.0133 mSv/MBq
Standard Deviation 0.00313
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Brain
|
0.00789 mSv/MBq
Standard Deviation 0.00075
|
0.00606 mSv/MBq
Standard Deviation 0.00132
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Breasts
|
0.00595 mSv/MBq
Standard Deviation 0.000974
|
0.00457 mSv/MBq
Standard Deviation 0.00044
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Gallbladder Wall
|
0.0756 mSv/MBq
Standard Deviation 0.0662
|
0.0713 mSv/MBq
Standard Deviation 0.0353
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
LLI Wall
|
0.0447 mSv/MBq
Standard Deviation 0.00236
|
0.0376 mSv/MBq
Standard Deviation 0.00314
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Small Intestine
|
0.117 mSv/MBq
Standard Deviation 0.00513
|
0.0925 mSv/MBq
Standard Deviation 0.00864
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Stomach Wall
|
0.0141 mSv/MBq
Standard Deviation 0.000929
|
0.0106 mSv/MBq
Standard Deviation 0.000758
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
ULI Wall
|
0.127 mSv/MBq
Standard Deviation 0.00513
|
0.105 mSv/MBq
Standard Deviation 0.00974
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Kidneys
|
0.0429 mSv/MBq
Standard Deviation 0.0119
|
0.037 mSv/MBq
Standard Deviation 0.00705
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Liver
|
0.101 mSv/MBq
Standard Deviation 0.0183
|
0.0702 mSv/MBq
Standard Deviation 0.0034
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Lungs
|
0.0145 mSv/MBq
Standard Deviation 0.000833
|
0.0138 mSv/MBq
Standard Deviation 0.00191
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Muscle
|
0.0093 mSv/MBq
Standard Deviation 0.000663
|
0.00732 mSv/MBq
Standard Deviation 0.000499
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Pancreas
|
0.0167 mSv/MBq
Standard Deviation 0.00150
|
0.0128 mSv/MBq
Standard Deviation 0.000379
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Red Marrow
|
0.0104 mSv/MBq
Standard Deviation 0.000636
|
0.00841 mSv/MBq
Standard Deviation 0.000637
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Testes
|
—
|
0.00606 mSv/MBq
Standard Deviation 0.000261
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Thymus
|
0.00667 mSv/MBq
Standard Deviation 0.00117
|
0.00513 mSv/MBq
Standard Deviation 0.00064
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Thyroid
|
0.00472 mSv/MBq
Standard Deviation 0.00107
|
0.00388 mSv/MBq
Standard Deviation 0.00064
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Urinary Bladder Wall
|
0.129 mSv/MBq
Standard Deviation 0.0472
|
0.112 mSv/MBq
Standard Deviation 0.0198
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Uterus
|
0.0258 mSv/MBq
Standard Deviation 0.00225
|
0.0213 mSv/MBq
Standard Deviation 0.0007
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Total Body
|
0.0134 mSv/MBq
Standard Deviation 0.000808
|
0.0103 mSv/MBq
Standard Deviation 0.000552
|
|
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Effective dose (ED, ICRP-60)
|
0.0303 mSv/MBq
Standard Deviation 0.0008
|
0.0245 mSv/MBq
Standard Deviation 0.000436
|
PRIMARY outcome
Timeframe: Up to 5 daysAn AE is the appearance or worsening of any undesirable sign, symptom, or medical condition, even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation during any phase of the study. Medical conditions/diseases present before starting study drug are only considered AEs if they worsen after starting study drug. Abnormal laboratory values or test results constitute AEs only if they induce clinical signs or symptoms, are considered clinically significant, or require therapy.
Outcome measures
| Measure |
[18F]GTP1
n=6 Participants
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
[18F]GTP1 Male
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
1 Participants
|
—
|
Adverse Events
[18F]GTP1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
[18F]GTP1
n=6 participants at risk
Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV).
|
|---|---|
|
Vascular disorders
Haematoma
|
16.7%
1/6 • Number of events 1 • Baseline up to 5 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER