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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Diagnostic test: [18F]GTP1

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Invicro, a Konica Minolta company

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Collaborators: Invicro

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): October 9, 2020
• Study Completion (Actual): October 9, 2020

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: GN42043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No