Exploratory Evaluation of [11C]-NOP46

NCT03705819 | Completed Early Phase 1 FDA Drug

• 1 other identifier: AAAQ8138
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

[11C]-NOP46

Outcome Measures

Primary Outcomes (1)

• Uptake ratio for site with pain is >1

  The uptake ratio for the site with pain to the site without pain is greater than 1 in the focal pain subjects

  48 hours post-scan

Secondary Outcomes (1)

• Occurrence of Physiologic Effects of Single Micro-dose of [11C]-NOP46

  48 hours post-scan

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

In Stage 1, five healthy volunteers will receive a microdose of \[11C\]-NOP46 and undergo serial whole body PET/CT scans for up to 240 minutes post-administration. These image sets will be used to evaluate \[11C\]-NOP46 biodistribution and derive dosimetry estimates.

Drug: [11C]-NOP46; Radiation: PET/CT scan

Individuals with Focal Pain

EXPERIMENTAL

In Stage 2, up to 30 subjects with focal pain will receive a microdose of \[11C\]-NOP46 and undergo PET/CT scans for up to 60 minutes in length. The results of Stage 1 will inform the scanning parameters (uptake period, scan length, reconstruction parameters, etc.) for Stage 2.

Drug: [11C]-NOP46; Radiation: PET/CT scan

Interventions

[11C]-NOP46 DRUG

Subjects will receive a microdose (≤10 µg) of \[11C\]-NOP46.

Healthy Volunteers; Individuals with Focal Pain

PET/CT scan RADIATION

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.

Healthy Volunteers; Individuals with Focal Pain

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (4)

• Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. 2010 Dec;105 Suppl 1:i69-85. doi: 10.1093/bja/aeq323.

  PMID: 21148657 BACKGROUND

• Jamison RN, Serraillier J, Michna E. Assessment and treatment of abuse risk in opioid prescribing for chronic pain. Pain Res Treat. 2011;2011:941808. doi: 10.1155/2011/941808. Epub 2011 Oct 11.

  PMID: 22110936 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.

  PMID: 22048730 BACKGROUND

• Pike VW. PET radiotracers: crossing the blood-brain barrier and surviving metabolism. Trends Pharmacol Sci. 2009 Aug;30(8):431-40. doi: 10.1016/j.tips.2009.05.005. Epub 2009 Jul 16.

  PMID: 19616318 BACKGROUND

Related Links

• Centers for Disease Control and Prevention (2011). Prescription painkiller overdoses in the U.S.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Akiva Mintz, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label Study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: March 25, 2019
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)