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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

[18F]GTP1

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Invicro, a Konica Minolta company

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]GTP1

Arm Description

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

Outcomes

Primary Outcome Measures

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).

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04394845

First Posted

May 14, 2020

Last Updated

October 5, 2021

Sponsor

Genentech, Inc.

Collaborators

Invicro

1. Study Identification

Unique Protocol Identification Number

NCT04394845

Brief Title

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

Official Title

Assessment of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 11, 2020 (Actual)

Primary Completion Date

October 9, 2020 (Actual)

Study Completion Date

October 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

Collaborators

Invicro

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

[18F]GTP1

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

[18F]GTP1

Other Intervention Name(s)

[18F]G02941054

Intervention Description

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

Primary Outcome Measure Information:

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

Title

Source Organ Residence Time (Total Number of Disintegrations)

Description

Time Frame

Day 1

Title

Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology

Description

Time Frame

Day 1

Title

Percentage of Participants With Adverse Events

Description

Time Frame

Up to 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Invicro, a Konica Minolta company

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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).

Learn more about this trial

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

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