Healthy Adult ParticipantsEarly Phase 1NCT07457736
Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
A Early Phase 1 study testing [ 18F]GATT-44 in people with Healthy Adult Participants, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- [ 18F]GATT-44
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to Jan 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University PET Center
New Haven, Connecticut, 06519
Shannan Henry, +1 (203) 737-5278, shannan.henry@yale.edu
Kayla R Cottiers, 203-737-7496, kayla.cottiers@yale.edu
About this study
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.
- Conditions
- Healthy Adult Participants
- Being tested
- [ 18F]GATT-44
- Keywords
- gatt44, experimental radiotracer, first in human radiotracer, GAT-1, GATT-44
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[ 18F]GATT-44Drug
Also called [18F]GAT44
First in human radiotracer being evaluated in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Drug: [ 18F]GATT-44 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: PET Scan Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start28 Jan 2026
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Richard Carson, Yale University
- Investigators
- Richard E Carson, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457736
- Sponsor's protocol ID
- 2000041030
- Other IDs
- 2U01MH107803-06
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
- ClinicalTrials.gov ID
- NCT07457736
- Acronym / sponsor ID
- 2000041030
- Conditions
- Healthy Adult Participants
- Keywords
- gatt44, experimental radiotracer, first in human radiotracer, GAT-1, GATT-44
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control - Test/Retest | Experimental | Drug: [ 18F]GATT-44In 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 |
| Healthy Control - Test-Blocking | Experimental | Drug: [ 18F]GATT-44In Part 2, we will conduct a test-blocking study to assess specific binding levels of [18F]GATT44 in humans. |
| Healthy Control - Whole Body | Experimental | Drug: [ 18F]GATT-44In Part 3, human dosimetry of [18F]GATT44 will be estimated by performing whole-body imaging studies |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [ 18F]GATT-44Also: [18F]GAT44First in human radiotracer being evaluated in this study. | Drug | Healthy Control - Test-Blocking, Healthy Control - Test/Retest, Healthy Control - Whole Body |
Primary outcome
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.
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).
Whole body radiation dosimetry calculated from PET-CT images
Time frame: PET Scan Day 1
Radiation absorbed doses of each organ will be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard E Carson, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [ 18F]GATT-44 in people with Healthy Adult Participants, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannan Henry (+1 (203) 737-5278, shannan.henry@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-Retest reproducibility calculations (time frame: PET Day 1 and PET Day 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.