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

Genentech

Status and phase

Completed

Phase 1

Conditions

Alzheimer Disease

Treatments

Diagnostic Test: [18F]GTP1

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04394845

GN42043

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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