Carbon-11 Butanol: Whole Body Radiochemical and Radiation Safety

Completed · Early Phase 1

Conditions studied: Neuro-Degenerative Disease

In brief

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.

Key facts

Study ID

NCT04050800

Run by

Weill Medical College of Cornell University

People needed

5

Starts

2020-09-17

Expected to finish

2021-01-05

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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