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A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04394845
Collaborator
Invicro (Other)
6
Enrollment
1
Location
1
Arm
1.9
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: [18F]GTP1
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Subjects
Actual Study Start Date :
Aug 11, 2020
Actual Primary Completion Date :
Oct 9, 2020
Actual Study Completion Date :
Oct 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: [18F]GTP1

Participants will receive a single bolus injection of radioligand [18F]GTP1 intravenously (IV).

Diagnostic Test: [18F]GTP1
[18F]GTP1 IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie [mCi]), with a maximum drug mass dose of 10 microgram (μg).
Other Names:
  • [18F]G02941054

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) [Day 1]

      Decay corrected [18F]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).

    2. Source Organ Residence Time (Total Number of Disintegrations) [Day 1]

      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

    3. Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology [Day 1]

      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

    4. Percentage of Participants With Adverse Events [Up to 5 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key inclusion criteria:

    • Healthy with no clinically relevant finding on physical examination at screening and prior to radiopharmaceutical administration

    • Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 30 days after the final dose

    • Male participants with partners of childbearing potential must commit to the use of two methods of contraception for the study duration and 90 days after the last dose

    • Male participants must not donate sperm for the duration of the study and 90 days after the last dose

    • Participants must have both Japanese parents and all Japanese grandparents

    Key exclusion criteria:

    • Participants with any significant medical disorder or disease expected to interfere with the study

    • Current or prior history (within a six-month period) of exposure to nicotine products

    • History of drug or alcohol abuse within 12 months prior to screening

    • Prior participation in other research protocols or clinical care in the last year, such that radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSv), the allowable annual limit for research participants as established by the US Federal Guidelines

    • Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing

    • Use of over the counter (OTC) medication, dietary supplements, or vitamins, within 2 weeks prior to initial dosing

    • Known hypersensitivity to any component of the formulation of [18F]GTP1 or related compounds

    • Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing

    • History of immunodeficiency diseases, including positive human immunodeficiency virus (HIV) test

    • Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody

    • Women who are pregnant, lactating or breastfeeding

    • Unsuitable veins for repeated venipuncture

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Invicro, a Konica Minolta company New Haven Connecticut United States 06510

    Sponsors and Collaborators

    • Genentech, Inc.
    • Invicro

    Investigators

    • Study Director: Clinical Trials, Genentech, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT04394845
    Other Study ID Numbers:
    • GN42043
    First Posted:
    May 19, 2020
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    Participant Flow

    Recruitment Details Screening assessments were completed within 30 days of Day 1.
    Pre-assignment Detail
    Arm/Group Title [18F]GTP1
    Arm/Group Description Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
    Period Title: Overall Study
    STARTED 6
    COMPLETED 6
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title [18F]GTP1
    Arm/Group Description Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
    Overall Participants 6
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    5
    83.3%
    >=65 years
    1
    16.7%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    51.33
    (15.11)
    Sex: Female, Male (Count of Participants)
    Female
    3
    50%
    Male
    3
    50%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    6
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    6
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    0
    0%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Weight (Kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Kg]
    55.32
    (11.29)

    Outcome Measures

    1. Primary Outcome
    Title Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
    Description Decay corrected [18F]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).
    Time Frame Day 1

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title [18F]GTP1
    Arm/Group Description Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
    Measure Participants 6
    Mean collect time: 5.32767 minutes
    0.33530
    (0.18795)
    Mean collect time: 16.38604 minutes
    0.59398
    (0.11540)
    Mean collect time: 32.41194 minutes
    2.13730
    (0.76985)
    Mean collect time: 53.21428 minutes
    4.89330
    (1.41690)
    Mean collect time: 78.27645 minutes
    9.38103
    (3.07024)
    Mean collect time: 97.78638 minutes
    12.93725
    (4.91340)
    Mean collect time: 144.06733 minutes
    20.76320
    (5.05449)
    Mean collect time: 187.27612 minutes
    25.22968
    (6.09050)
    Mean collect time: 213.49112 minutes
    29.06417
    (9.29250)
    Mean collect time: 258.12780 minutes
    34.50070
    (9.38550)
    Mean collect time: 304.21875 minutes
    36.95242
    (10.99721)
    Mean collect time: 337.49112 minutes
    39.75663
    (10.21783)
    2. Primary Outcome
    Title Source Organ Residence Time (Total Number of Disintegrations)
    Description 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
    Time Frame Day 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title [18F]GTP1 Female [18F]GTP1 Male
    Arm/Group Description Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV). Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
    Measure Participants 3 3
    Brain
    0.0375
    (0.00295)
    0.0315
    (0.00717)
    Gallbladder Contents
    0.0254
    (0.038)
    0.0304
    (0.023)
    Gallbladder Contents with GB emptying model
    0.0102
    (0.012)
    0.0122
    (0.00637)
    LLI Cont.
    0.0416
    (0.00214)
    0.0396
    (0.00401)
    SI Cont.
    0.415
    (0.0219)
    0.395
    (0.0397)
    ULI Cont.
    0.228
    (0.0117)
    0.217
    (0.0219)
    Heart Wall
    0.0153
    (0.00326)
    0.019
    (0.00774)
    Kidneys
    0.046
    (0.0195)
    0.0448
    (0.0114)
    Liver
    0.591
    (0.112)
    0.532
    (0.0284)
    Lungs
    0.0346
    (0.00205)
    0.0523
    (0.0125)
    Spleen
    0.00634
    (0.00203)
    0.0074
    (0.00339)
    Urinary Bladder Contents
    0.135
    (0.047)
    0.237
    (0.0332)
    Urinary Bladder Contents with UB voiding model
    0.18
    (0.0717)
    0.222
    (0.0441)
    Remainder
    0.743
    (0.143)
    0.687
    (0.056)
    Remainder with UB voiding model
    0.708
    (0.181)
    0.675
    (0.127)
    Remainder with both UB voiding and GB emptying models
    0.723
    (0.161)
    0.693
    (0.12)
    3. Primary Outcome
    Title Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
    Description 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
    Time Frame Day 1

    Outcome Measure Data

    Analysis Population Description
    Testes not analyzed for female population.
    Arm/Group Title [18F]GTP1 Female [18F]GTP1 Male
    Arm/Group Description Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV). Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
    Measure Participants 3 3
    Adrenals
    0.0164
    (0.00156)
    0.0123
    (0.000451)
    Brain
    0.00789
    (0.00075)
    0.00606
    (0.00132)
    Breasts
    0.00595
    (0.000974)
    0.00457
    (0.00044)
    Gallbladder Wall
    0.0756
    (0.0662)
    0.0713
    (0.0353)
    LLI Wall
    0.0447
    (0.00236)
    0.0376
    (0.00314)
    Small Intestine
    0.117
    (0.00513)
    0.0925
    (0.00864)
    Stomach Wall
    0.0141
    (0.000929)
    0.0106
    (0.000758)
    ULI Wall
    0.127
    (0.00513)
    0.105
    (0.00974)
    Heart Wall
    0.0196
    (0.00309)
    0.0167
    (0.00439)
    Kidneys
    0.0429
    (0.0119)
    0.037
    (0.00705)
    Liver
    0.101
    (0.0183)
    0.0702
    (0.0034)
    Lungs
    0.0145
    (0.000833)
    0.0138
    (0.00191)
    Muscle
    0.0093
    (0.000663)
    0.00732
    (0.000499)
    Ovaries
    0.0276
    (0.00133)
    0.0216
    (0.00379)
    Pancreas
    0.0167
    (0.00150)
    0.0128
    (0.000379)
    Red Marrow
    0.0104
    (0.000636)
    0.00841
    (0.000637)
    Osteogenic Cells
    0.0107
    (0.00161)
    0.00787
    (0.000946)
    Skin
    0.0055
    (0.000749)
    0.00428
    (0.000441)
    Spleen
    0.0156
    (0.00253)
    0.0133
    (0.00313)
    Testes
    0.00606
    (0.000261)
    Thymus
    0.00667
    (0.00117)
    0.00513
    (0.00064)
    Thyroid
    0.00472
    (0.00107)
    0.00388
    (0.00064)
    Urinary Bladder Wall
    0.129
    (0.0472)
    0.112
    (0.0198)
    Uterus
    0.0258
    (0.00225)
    0.0213
    (0.0007)
    Total Body
    0.0134
    (0.000808)
    0.0103
    (0.000552)
    Effective dose (ED, ICRP-60)
    0.0303
    (0.0008)
    0.0245
    (0.000436)
    4. Primary Outcome
    Title Percentage of Participants With Adverse Events
    Description 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.
    Time Frame Up to 5 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title [18F]GTP1
    Arm/Group Description Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
    Measure Participants 6
    Number [Participants]
    1
    16.7%

    Adverse Events

    Time Frame Baseline up to 5 days
    Adverse Event Reporting Description
    Arm/Group Title [18F]GTP1
    Arm/Group Description Participants received a single bolus injection of radioligand [18F]GTP1 intravenously (IV).
    All Cause Mortality
    [18F]GTP1
    Affected / at Risk (%) # Events
    Total 0/6 (0%)
    Serious Adverse Events
    [18F]GTP1
    Affected / at Risk (%) # Events
    Total 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    [18F]GTP1
    Affected / at Risk (%) # Events
    Total 1/6 (16.7%)
    Vascular disorders
    Haematoma 1/6 (16.7%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800 821-8590
    Email global-roche-genentech-trials@gene.com
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT04394845
    Other Study ID Numbers:
    • GN42043
    First Posted:
    May 19, 2020
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Sep 1, 2021