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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394845
• Other study ID #: GN42043
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2020
• Est. completion date: October 9, 2020

Study information

• Verified date: September 2021
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 9, 2020
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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).

Locations

Country	Name	City	State
United States	Invicro, a Konica Minolta company	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Invicro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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