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Exploratory Evaluation of [11C]-NOP46

NCT03705819 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Akiva Mintz, MD, PhD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2023-10-30
Completion
2023-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705819 on ClinicalTrials.gov