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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Diagnostic Test: [18F]GTP1

• Registration Number: NCT04394845
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Study Start: 2020-08-11
• Primary Completion: 2020-10-09
• Study Completion: 2020-10-09
• Status Verified: 2021-09
• Results First Submitted: 2021-10-05
• Results First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Results First Posted: 2021-11-03
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)	Day 1	Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).
Source Organ Residence Time (Total Number of Disintegrations)	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
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology	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
Percentage of Participants With Adverse Events	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.

Trial Locations

Locations (1)

Invicro, a Konica Minolta company; 🇺🇸 New Haven, Connecticut, United States