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NCT Number: NCT04394845

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Invicro, a Konica Minolta company

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[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).

Other names: [18F]G02941054

Primary outcomes

  1. Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)

    Time frame: Day 1

    Decay corrected [18F]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).

  2. Source Organ Residence Time (Total Number of Disintegrations)

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

  4. Percentage of Participants With Adverse Events

    Time frame: Up to 5 days

    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.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Invicro

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 19, 2020
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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