Recruiting

Phase 1

(S)-[18F]FBFP & (R)-[18F]FBFPPET Imaging of the sigma1 Receptor in Healthy Adults

Sponsor:

Yale University

Code:

NCT07915323

Conditions

Healthy Control Subjects

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

(S)-[18F] FBFP or (R)-[18F]FBFP

Study Details

Brief summary:

Evaluate (S)-\[18F\]FBFP and (R)-\[18F\]FBFP, sigma-1 radiotracers, in humans, to characterize their pharmacokinetic, metabolic, and in vivo binding profiles, assess feasibility for quantitative kinetic modeling analysis of imaging data, and determine the reliability and reproducibility of kinetic and binding parameters.

Assess specific binding levels of (S)-\[18F\]FBFP or (R)-\[18F\]FBFP by conducting test-block studies in humans.

Conditions

Healthy Control Subjects

Study ID

NCT07915323

Start date

Oct 1, 2025

Status verified date

Sep, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Test/blocking PET scans for healthy controls

A test-blocking study to assess specific binding levels of (S)-\[18F\] FBFP or (R)-\[18F\]FBFP in humans. A total of 10 healthy subjects will undergo two PET scans on two separate days, with the second scan at 4 h (Tmax) after an oral dose of 10 mg donepezil.

Each subject will also undergo one MRI scan for anatomical identification of brain regions.

Interventions

(S)-[18F] FBFP or (R)-[18F]FBFP

Novel radioisotope aimed at imaging the sigma1 receptors in the brain

Primary outcome measure

Test-Blocking measurements, based on quantitative analysis of PET imaging data. [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Shannan Henry

203-737-5278 shannan.henry@yale.edu

Mark F Dias

203-737-6128 mark.dias@yale.edu

Locations

Yale University PET Center

Recruiting

New Haven, Connecticut, United States, 06519

More Information

Sponsor

Yale University

Last update posted

Nov 4, 2026

Last verified

Sep, 2026

Keywords

first in human
PET scans
sigma1 receptor
neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Yale University on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.