Carbon-11 Butanol: Whole Body Radiochemical and Radiation Safety

NCT04050800 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 19-05020069
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial scans acquired every 3 minutes for two hours. Vital signs (VS), electrocardiograms (ECGs) and clinical laboratory tests of intrernal organ function will be acquired before and at several timepoints after administration of the radiopharmaceutical. Radiation exposures will be estimated with the MIRD Formalism.

Conditions

Neuro-Degenerative Disease

Outcome Measures

Primary Outcomes (1)

• Effective Dose (ED)

  Fundamental radiation dose quantity in the International Commission on Radiological Protection (ICRP) system of radiological protection. Calculated with OLINDA-EXM software (OLINDA/EXM stands for Organ Level INternal Dose Assessment/EXponential Modeling).

  Day 1, from the measurements of exposures during the first 2 hours post administration.

Secondary Outcomes (5)

• Change in Radiochemical Safety Assessments

  Pulse at two hours post administration compared to pulse shortly before administration.

• Change in Radiochemical Safety Assessments

  Blood pressure at two hours post administration compared to blood pressure shortly before administration.

• Change in Radiochemical Safety Assessments

  At two hours post administration compared to same parameters shortly before administration.

• Change in number of Subjects with prolonged PR interval greater than 20 mSec

  At two hours post administration compared to same parameters shortly before administration.

• Change in number of subjects with QTc >440 mSec

  At two hours post administration compared to same parameters shortly before administration.

Study Arms (1)

Healthy Controls

EXPERIMENTAL

Subjects will be administered two sequential doses of the radiopharmaceutical under nearly zero-biological-change conditions.

Drug: Carbon 11 Butanol

Interventions

Carbon 11 Butanol DRUG

Two sequential administrations of a PET tracer

Also known as: [11C]Butan-1-Ol

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to give informed consent.
• age 18-89
• Subjectively healthy and, in the opinion of the investigators, likely to tolerate the imaging procedures and be compliant with the schedule of follow up telephone calls.
• Normal hemodynamic function. Systolic blood pressure and pulse must be higher than 120 mmHg and 60 beats per minute while sitting. At the discretion of the investigators, people who regularly engage in vigorous exercise more than four times per week may be enrolled if their systolic blood pressure and pulse are higher than 100 mmHg and 50 beats per minute while sitting.
• Unremarkable electrocardiograms, with PR intervals of less than 200 mSec and QTcF intervals (corrected with Frederica's method) of less than 440 mSec.
• No concurrent medications with the exception of p.r.n. NSAIDS, which must be discontinued one week prior to PET scanning.
• Willing and able to refrain from abusing any recreational drugs, including marijuana, and drink less than one unit of alcoholic beverages per day starting one week prior to PET scanning, and avoided for the next four weeks.
• Willing to refrain from donating blood for four (4) weeks before the study and for four (4) weeks after the study.
• Willing to refrain from participating in any other research study that requires taking medication for four (4) weeks before the study and for four (4) weeks after the study.
• Willing to refrain from being vaccinated for four (4) weeks before the study and for four (4) weeks after the study.
• All clinical laboratory test results within normal limits or not clinically significant. For example, elevated bilirubin levels in subjects with Gilbert's syndrome will be allowed, as will small red blood cell volumes in healthy people with sickle cell trait.

You may not qualify if:

• Subjects may not be a member of a vulnerable population.
• Women may not be pregnant or breast feeding.
• History of multiple hypersensitivity reactions (atopia), as indicated by allergies to multiple medications, foods, and seasonal pollens.
• History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination (ADME) of the tracer, including chronic liver or renal failure.
• Positive urine toxicology screen for recreational drugs other than marijuana.
• May not have taken any controlled medications, including other study drugs, in the 30 days prior to PET scanning or for 10 half-lives, whichever is longer.
• May not have donated blood in the 30 days prior to PET scanning.
• May not have participated in research administering drugs in the last 30 days.
• May not have been vaccinated in the 30 days prior to PET scanning.
• May not have been exposed to radiation during research of more than 10 mSv during the last year.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Study Officials

• P. David Mozley, MD

  Cornell University Weill College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: September 17, 2020
• Primary Completion: December 29, 2020
• Study Completion: January 5, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon publication of the results.
• Access Criteria: Any investigators with a reasonable request for the data.

Locations

US (1)