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| Name | Class |
|---|---|
| Invicro | OTHER |
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The purpose of this study is to evaluate the biodistribution, safety and tolerability of a single dose of [18F]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]GTP1 | Experimental | Participants will receive a single bolus injection of radioligand [18F]GTP1 intravenously (IV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]GTP1 | Diagnostic Test | [18F]GTP1 IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie [mCi]), with a maximum drug mass dose of 10 microgram (μg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Decay corrected [18F]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID). | Day 1 |
| Source Organ Residence Time (Total Number of Disintegrations) | Source 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 | Day 1 |
| Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | 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 | Day 1 |
| Percentage of Participants With Adverse Events | An 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. | Up to 5 days |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invicro, a Konica Minolta company | New Haven | Connecticut | 06510 | United States |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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Screening assessments were completed within 30 days of Day 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | [18F]GTP1 | Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | [18F]GTP1 | Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Decay corrected [18F]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID). | 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. | Posted | Mean | Standard Deviation | Percentage of Injected Dose | Day 1 |
|
Baseline up to 5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [18F]GTP1 | Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA version 23.1. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | global-roche-genentech-trials@gene.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2020 | Oct 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kg |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Source Organ Residence Time (Total Number of Disintegrations) | Source 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 | Posted | Mean | Standard Deviation | MBq x hour/MBq | Day 1 |
|
|
|
| Primary | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | 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 | Testes not analyzed for female population. | Posted | Mean | Standard Deviation | mSv/MBq | Day 1 |
|
|
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| Primary | Percentage of Participants With Adverse Events | An 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. | Posted | Number | Participants | Up to 5 days |
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| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
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.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Gallbladder Contents with GB emptying model |
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| LLI Cont. |
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| SI Cont. |
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| ULI Cont. |
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| Heart Wall |
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| Kidneys |
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| Liver |
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| Lungs |
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| Urinary Bladder Contents |
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| Urinary Bladder Contents with UB voiding model |
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| Remainder |
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| Remainder with UB voiding model |
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| Remainder with both UB voiding and GB emptying models |
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| Brain |
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| Breasts |
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| Gallbladder Wall |
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| LLI Wall |
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| Small Intestine |
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| ULI Wall |
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| Heart Wall |
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| Kidneys |
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| Liver |
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| Lungs |
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| Muscle |
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| Ovaries |
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| Pancreas |
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| Red Marrow |
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| Osteogenic Cells |
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| Skin |
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| Spleen |
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| Testes |
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| Thymus |
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| Thyroid |
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| Urinary Bladder Wall |
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| Uterus |
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| Total Body |
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| Effective dose (ED, ICRP-60) |
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