Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1

April 2, 2026 updated by: Richard Carson, Yale University
Evaluate [18F]GATT-44 (aka [18F]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of [18F]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of [18F]GATT-44 by performing whole-body imaging studies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University PET Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard E Carson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Willing and able to give voluntary written informed consent;
  2. Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff;
  3. Male or female, aged 18 to 60, at screening;
  4. In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests;
  5. Females of childbearing potential, and male subjects, must be willing to practice birth control for the duration of the study (unless medical documentation is provided confirming subject is permanently sterile).

Exclusion:

  1. Less than 18 years of age;
  2. Pregnant or breastfeeding;
  3. Any significant systemic illness or unstable medical condition;
  4. Pre-existing medical conditions or claustrophobic reactions;
  5. Research-related radiation exposure exceeds current PET Center guidelines;
  6. History of a bleeding disorder or are currently taking anticoagulants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Control - Test/Retest
In Part 1 we will conduct a test/retest study of the novel GABA Transporter (GAT-1) imaging tracer [18F]GATT44 in humans, to characterize its pharmacokinetic behavior and determine the reliability and reproducibility of in vivo pharmacokinetic parameter measurements
Drug: [ 18F]GATT-44
First in human radiotracer being evaluated in this study.
Other Names:
  • [18F]GAT44
Experimental: Healthy Control - Test-Blocking
In Part 2, we will conduct a test-blocking study to assess specific binding levels of [18F]GATT44 in humans.
Drug: [ 18F]GATT-44
First in human radiotracer being evaluated in this study.
Other Names:
  • [18F]GAT44
Experimental: Healthy Control - Whole Body
In Part 3, human dosimetry of [18F]GATT44 will be estimated by performing whole-body imaging studies
Drug: [ 18F]GATT-44
First in human radiotracer being evaluated in this study.
Other Names:
  • [18F]GAT44

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test-Retest reproducibility calculations
Time Frame: PET Day 1 and PET Day 2
Regional TACs are analyzed with kinetic models to generate regional volume of distribution (VT), using the metabolite-corrected arterial plasma concentrations over time as input function. Standardized uptake values (SUV) may also be generated.
PET Day 1 and PET Day 2
Specific binding levels of [18F]GATT44 in humans.
Time Frame: PET Day 1 and PET Day 2
Binding potentials BPF, BPP, and BPND will be calculated from VT values, and reference models. White Matter will be the reference region to estimate nondisplaceable binding (VND).
PET Day 1 and PET Day 2
Whole body radiation dosimetry calculated from PET-CT images
Time Frame: PET Scan Day 1
Radiation absorbed doses of each organ will be calculated.
PET Scan Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Richard E Carson, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2000041030
  • 2U01MH107803-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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