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

NCT04394845 | Completed Phase 1 Results FDA Drug

• 1 other identifier: GN42043
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

[18F]GTP1

EXPERIMENTAL

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

Diagnostic Test: [18F]GTP1

Interventions

[18F]GTP1 DIAGNOSTIC_TEST

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

Also known as: [18F]G02941054

[18F]GTP1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead
• Invicro: collaborator

Study Sites (1)

Invicro, a Konica Minolta company

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

global-roche-genentech-trials@gene.com

800 821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: August 11, 2020
• Primary Completion: October 9, 2020
• Study Completion: October 9, 2020
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)