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

NCT ID: NCT04394845

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2020-10-09

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[18F]GTP1

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

Group Type: EXPERIMENTAL

[18F]GTP1

Intervention Type: 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).

Interventions

[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).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

[18F]G02941054

Eligibility Criteria

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
• Women who are pregnant, lactating or breastfeeding
• Unsuitable veins for repeated venipuncture

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Invicro

OTHER

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Invicro, a Konica Minolta company

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GN42043

Identifier Type: -

Identifier Source: org_study_id