Pet imaging of sigma1 receptors in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, first-in-human trial uses (S)-[18F]FBFP and (R)-[18F]FBFP PET tracers to characterize how the tracers behave in the body, including how they are metabolized and how they bind in the brain. The study aims to determine the feasibility of quantitative kinetic modeling from PET data and to assess the reliability and reproducibility of binding parameters. Test-block studies will assess specific binding levels in humans. Participants are healthy adults who will undergo PET imaging and related assessments under careful monitoring. The trial is led by Yale University with collaboration from the National Institute on Aging and is located at the Yale University PET Center in New Haven, CT.

Why it matters

Who can join: the full rules

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 Criteria:

* History or presence of clinically significant respiratory, GI, renal, hepatic, pancreatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders, including all cancers.
* Laboratory tests with clinically significant abnormalities or positive urine toxicology, at screening.
* Abnormal and clinically significant ECG, as (as determined by the Investigator or his/her designee) at screening.
* Seropositive for hepatitis B, hepatitis C, and/or HIV (tested during screening).
* Pregnancy or lactation
* Use of prescription medications within 14 days of PET scanning or antibiotics within 30 days of PET scanning. Exceptions may be allowed only if the medication's administration is deemed unlikely to impact the study result.
* Treatment with another investigational drug or other intervention within 1 week of the screening visit.
* Current smoker.
* History of alcohol or drug abuse, within 2 years prior to screening, as determined by the investigator.
* MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects/fragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).
* Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for healthy volunteers.
* Subjects with a history of IV drug use that would prevent venous access for PET tracer injection.
* Subject who has current, past, or anticipated exposure to radiation in the work place within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
* Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
* Arterial Line Exclusion: Blood donation within eight weeks of the start of the study.
* Arterial Line Exclusion: History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
* Arterial Line Exclusion: PT and PTT greater than 5msec above the upper limit of normal.
* Arterial Line Exclusion: Unable to safely discontinue or hold aspirin and other NSAID use

Where it's running

• Yale University PET Center
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Henry Huang — Yale University
• Study coordinator: Shannan Henry
• Email: shannan.henry@yale.edu
• Phone: 203-737-5278

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.