Radiocaine Safety Study (NCT07081217) | Clinical Trial Compass
RecruitingEarly Phase 1
Radiocaine Safety Study
United States6 participantsStarted 2025-06-17
Plain-language summary
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaineâ„¢, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels. The study enrolls adult volunteers and aims to inform future clinical development in molecular imaging applications. Radiocaineâ„¢ is being developed as a potential diagnostic imaging agent and imaging biomarker for the localization and quantification of sodium channel activity.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 18 years and older
* Able to provide written consent
* Willing and able to undergo ECG, imaging, blood sampling, and complete self-assessment rating scales at the specified time points
* Unremarkable baseline health without report of chronic or acute pain
* Willing and able to participate in all imaging procedures and complete the self-assessment rating scales at the specified time points
Exclusion Criteria:
* Body mass index (BMI) of 32 or greater, weight \>300 lbs
* Diagnosis of severe depression/anxiety (PROMIS score \> 95%) or suicidal ideation
* History of opioid abuse or opioid use disorder
* History of seizures or epilepsy
* History of major Axis I or Axis II psychiatric disorder that might, in the opinion of the investigator, make it difficult for the subject to complete all the procedures (e.g. obsessive-compulsive disorder, bipolar disorder, schizophrenia, or schizoaffective disorder)
* History of cardiac arrhythmia
* History of major orthopedic surgery within the last 12 months
* Recent history (previous 6 months) of sodium channel blocker use, including, but not limited to: carbamazepine, lamotrigine, lidocaine, phenytoin, propranolol, or valproate
* Any significant systemic illness or medical condition that could lead to difficulty complying with the study protocol
* Creatinine clearance (calculated using the Cockcroft-Gault formula or measured) \< 60 mL/min or serum creatinine \>1.5 x ULN
* QTcF \>470 msec for females and QTcF \>450 msec…