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

NCT04394845 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-11-03

Study results available
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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.

Conditions

  • Alzheimer Disease

Interventions

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).

Sponsors & Collaborators

  • Invicro

    collaborator OTHER

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2020-10-09
Completion
2020-10-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394845 on ClinicalTrials.gov