Status:
COMPLETED
Carbon-11 Butanol: Whole Body Radiochemical and Radiation Safety
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Neuro-Degenerative Disease
Eligibility:
All Genders
18-89 years
Phase:
EARLY_PHASE1
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 ...
Detailed Description
Vital signs (VSs) will be measured, electrocardiograms (ECGs) will be acquired, and blood will be sent to the clinical laboratory for safety assessments before a single dose, intravenous (IV) administ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04050800
Start Date
September 17 2020
End Date
January 5 2021
Last Update
June 18 2021
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10065