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New treatment option for Healthy Adult Participants
Official title Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
ClinicalTrials.gov ID: NCT07457736
What this study is testing
What is [ 18F]GATT-44?
[ 18F]GATT-44 is an investigational medicine, being studied as a potential treatment for healthy adult participants.
Also referred to as [18F]GAT44.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join 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...
- 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 people, must be willing to practice birth control for the duration of the study (unless medical...
See the full eligibility 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 people, 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.