Healthy Control SubjectsPhase 1sigma1_fihNCT07915323
PET Imaging of the sigma1 Receptor in Healthy Adults
A Phase 1 study testing (S)-[18F] FBFP or (R)-[18F]FBFP in people with Healthy Control Subjects, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Healthy Control Subjects
- What is being tested?
- (S)-[18F] FBFP or (R)-[18F]FBFP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 May 2028
- Phase
- 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
- No healthy volunteers
- 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
- 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.
Show all 18Show fewer
- 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
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
About this study
Official title: Evaluation of (S)-[18F] FBFP and (R)-[18F] FBFP as a Radioligands for Positron Emission Tomography Imaging of the Sigma-1 Receptor
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
- Being tested
- (S)-[18F] FBFP or (R)-[18F]FBFP
- Keywords
- first in human, PET scans, sigma1 receptor, neuroimaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(S)-[18F] FBFP or (R)-[18F]FBFPDrug
Novel radioisotope aimed at imaging the sigma1 receptors in the brain
| Study group | Role | What they receive |
|---|---|---|
| Test/blocking PET scans for healthy controls | Experimental | 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. Receives: Drug: (S)-[18F] FBFP or (R)-[18F]FBFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-Blocking measurements, based on quantitative analysis of PET imaging data.
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 (S)-[18F]FBFP or (R)-[18F]FBFP in humans.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Oct 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Control SubjectsStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Henry Huang Huang, Yale University
- Investigators
- Henry Huang, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915323
- Sponsor's protocol ID
- 2000039920
- Other IDs
- R01AG076681-01A1
- Acronym
- sigma1_fih
- Status last verified
- Sep 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of (S)-[18F] FBFP and (R)-[18F] FBFP as a Radioligands for Positron Emission Tomography Imaging of the Sigma-1 Receptor
- ClinicalTrials.gov ID
- NCT07915323
- Acronym / sponsor ID
- sigma1_fih / 2000039920
- Conditions
- Healthy Control Subjects
- Keywords
- first in human, PET scans, sigma1 receptor, neuroimaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 4 Nov 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 (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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test/blocking PET scans for healthy controls | Experimental | Drug: (S)-[18F] FBFP or (R)-[18F]FBFPA 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not 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 (18 listed)
- 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
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 |
|---|---|---|
| (S)-[18F] FBFP or (R)-[18F]FBFPNovel radioisotope aimed at imaging the sigma1 receptors in the brain | Drug | Test/blocking PET scans for healthy controls |
Primary outcome
Test-Blocking measurements, based on quantitative analysis of PET imaging data.
Time frame: 4 years
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 (S)-[18F]FBFP or (R)-[18F]FBFP in humans.
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 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Control Subjects
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
Healthy Subjects
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
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.
Henry Huang 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 Phase 1 study testing (S)-[18F] FBFP or (R)-[18F]FBFP in people with Healthy Control Subjects, 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 18 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 4 Nov 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (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-Blocking measurements, based on quantitative analysis of PET imaging data. (time frame: 4 years). 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 4 Nov 2026.