NCT03705819

Exploratory Evaluation of [11C]-NOP46

Exploratory Evaluation of [11C]-NOP46 Pharmacokinetics With Positron Emission Tomography (PET)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

Pain is a natural response to injury. Pain lets us know there may be damage to our bodies. Pain is the way our body tells us that we must take care of ourselves. Chronic pain is different. Chronic pain is pain that lasts for a long time. Chronic pain can last for weeks, months, and even years. In some cases chronic pain remains without any sign of body damage. Today, there is no way for a doctor to measure someone's chronic pain or accurately determine many details about chronic pain. The investigators at Columbia University are interested in new imaging test that could help doctors look at chronic pain and help patients with chronic pain. The new imaging test uses a new drug called \[11C\]-NOP46. \[11C\]-NOP46 is a radioactive drug and is experimental. It is not approved by the Food and Drug Administration (FDA). The investigators believe that, when given to patients, this new drug can go to the exact places of chronic pain within the body. Once the drug goes to the places of chronic pain, a special camera, called a Positron Emission Tomography (PET) camera, can be used to take pictures of the drug. In this study, the investigators will give \[11C\]-NOP46 to up to 35 subjects.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	[11C]-NOP46	Subjects will receive a microdose (≤10 µg) of \[11C\]-NOP46.
RADIATION	PET/CT scan	After subjects receive a microdose of \[11C\]-NOP46, whole body PET/CT scan(s) will be performed to determine dosimetry and perform an initial safety evaluation of the radiotracer in Stage 1 and region of interests in Stage 2.

Timeline

• Start date: 2019-03-25
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2018-10-15
• Last updated: 2025-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study