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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07457736
Enrollment
32
Registered
2026-03-09
Start date
2026-01-28
Completion date
2030-01-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Participants

Keywords

gatt44, experimental radiotracer, first in human radiotracer, GAT-1, GATT-44

Brief summary

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.

Interventions

DRUG[ 18F]GATT-44

First in human radiotracer being evaluated in this study.

Sponsors

Yale University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Test-Retest reproducibility calculationsPET Day 1 and PET Day 2Regional 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.
Specific binding levels of [18F]GATT44 in humans.PET Day 1 and PET Day 2Binding 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).
Whole body radiation dosimetry calculated from PET-CT imagesPET Scan Day 1Radiation absorbed doses of each organ will be calculated.

Countries

United States

Contacts

CONTACTShannan Henry
shannan.henry@yale.edu+1 (203) 737-5278
CONTACTKayla R Cottiers
kayla.cottiers@yale.edu203-737-7496
PRINCIPAL_INVESTIGATORRichard E Carson, PhD

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026