Exploratory Evaluation of [11C]-NOP46

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single center design. In the first stage, five (5) healthy individuals will receive a microdose (10µg) of [11C]-NOP46, immediately followed by whole body positron emission tomography (PET)/computed tomography (CT) to determine dosimetry and perform an initial safety evaluation of the radiotracer. If no toxicities develop, then the investigation will move to the second stage, in which thirty (30) patients with chronic pain will receive a microdose of [11C]-NOP46 followed by PET/CT of region of interests.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Akiva Mintz

Criteria

Inclusion Criteria:

• All subjects must be 18 years of age or older, able to read, understand, and voluntarily sign an informed consent document.

For Healthy Volunteers:

• Volunteers must have no current medical history of sustained pain from a focal injury.

• Negative pregnancy test if female of childbearing potential.

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

Patients with Focal Pain:

• Subjects must have current pain from a focal injury for which they are under a physician's care.

• Subjects must have moderate to severe pain, defined as >4 on the Visual Analogue Scale

• Subjects must have a negative pregnancy test if female of childbearing potential.

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

Exclusion Criteria:

• Participants with evidence of diffuse pain at the time of enrollment up to agent administration are to be excluded from this study.

• Inability to discontinue pain medication(s) for 48 hours prior to agent administration.(Enrolled participants who have taken pain medication within 48 hours of agent administration may be either withdrawn from the study or rescheduled at the PI's discretion).

• Concomitant medication use (including suspected illicit drugs use) that, in the judgment of the investigator, would make the participant inappropriate for enrollment.

• Severe concurrent disease, infection, or medical co-morbidity that, in the judgment of the investigator, would make the participant inappropriate for enrollment.

• Participants who are receiving any other investigational agents.

• Women who are pregnant or breastfeeding.

• Subjects who are unable to tolerate PET/CT imaging.