NCT07457736

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1

Timeline
44mo left

Started Mar 2026

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Jan 2030

First Submitted

Initial submission to the registry

January 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 9, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

January 29, 2026

Last Update Submit

March 3, 2026

Conditions

Healthy Adult Participants

Keywords

gatt44experimental radiotracerfirst in human radiotracerGAT-1GATT-44

Outcome Measures

Primary Outcomes (3)

  • Test-Retest reproducibility calculations

    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.

    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

    Radiation absorbed doses of each organ will be calculated.

    PET Scan Day 1

Study Arms (3)

Healthy Control - Test/Retest

EXPERIMENTAL

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

Healthy Control - Test-Blocking

EXPERIMENTAL

In Part 2, we will conduct a test-blocking study to assess specific binding levels of \[18F\]GATT44 in humans.

Drug: [ 18F]GATT-44

Healthy Control - Whole Body

EXPERIMENTAL

In Part 3, human dosimetry of \[18F\]GATT44 will be estimated by performing whole-body imaging studies

Drug: [ 18F]GATT-44

Interventions

[ 18F]GATT-44DRUG

First in human radiotracer being evaluated in this study.

Also known as: [18F]GAT44
Healthy Control - Test-BlockingHealthy Control - Test/RetestHealthy Control - Whole Body

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University PET Center

New Haven, Connecticut, 06519, United States

RECRUITING

Study Officials

  • Richard E Carson, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannan Henry

CONTACT

+1 (203) 737-5278shannan.henry@yale.edu

Kayla R Cottiers

CONTACT

203-737-7496kayla.cottiers@yale.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology and Biomedical Imaging and of Biomedical Engineering

Study Record Dates

First Submitted

January 29, 2026

First Posted

March 9, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

March 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)