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NCT Number: NCT07457736

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

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.

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Key information

Conditions

Healthy Adult Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to give voluntary written informed consent;
  • 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;
  • Male or female, aged 18 to 60, at screening;
  • In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests;
  • 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:

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

Treatment and study plan

[ 18F]GATT-44

Drug

First in human radiotracer being evaluated in this study.

Other names: [18F]GAT44

Primary outcomes

  1. 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.

  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).

  3. Whole body radiation dosimetry calculated from PET-CT images

    Time frame: PET Scan Day 1

    Radiation absorbed doses of each organ will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla R Cottiers

CONTACT

[email protected]

203-737-7496

Shannan Henry

CONTACT

[email protected]

+1 (203) 737-5278

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 9, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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