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A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT04394845•Genentech, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

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
+2 more criteria

Locations (1)

Invicro, a Konica Minolta company

New Haven, Connecticut, United States

Key Dates

Start Date

August 11, 2020

Primary Completion Date

October 9, 2020

Completion Date

October 9, 2020

Last Updated

November 3, 2021

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

[18F]GTP1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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