Feasibility of Administering Clonidine as a Pharmacological Challenge in Imaging Studies

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    12
  • sponsor
    Weill Medical College of Cornell University
Updated on 25 January 2021
treatment regimen

Summary

This will be a Phase 1, open label study of the pharmacokinetics (PK) and pharmacodynamics (PD) of clonidine, an alpha-2 adrenergic (a2a) agonist, in healthy volunteers. The primary aim is to show that the drug regimen is safe and reasonably well tolerated. The secondary aim is to demonstrate that safety can be monitored with home health devices.

Description

Subjects who screen in will participate in a drug-free lead-in period of one week duration. Then, the drug test article, clonidine HCl, 0.1 mg tabs, will be administered once daily by mouth at bedtime for one week. Steady-state PK will be measured on Day 8 post-drug with a single blood draw of 10 mL. This will be followed by a one week wash out period. During each of these three different one-week periods, sleep quality will be monitored nightly with a blue tooth and wireless enabled, wearable sleep tracker. Vital signs (VSs) will be monitored daily at home with a blue tooth and wireless enabled blood pressure machine. VSs and electrocardiograms (ECGs) will be measured before drug on Day (-7) and Day 1. Repeat measurements will be made during clinic visits on Day 2, Day 8, and Day 16.

The findings should show that there is, or is not, a PD effect produced by this rather low dose of drug administered for a relatively short period of time. Showing a PD effect at a safe and reasonably well tolerated dose would qualify this drug dosing regimen as a pharmacological challenge in future studies.

Details
Condition Cancer, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neoplasms, Neuro-Degenerative Disease, Neuro-Degenerative Disease, Neuro-Degenerative Disease, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, Neuro-Degenerative Disease
Treatment Clonidine Pill
Clinical Study IdentifierNCT04030572
SponsorWeill Medical College of Cornell University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 89 yrs?
Gender: Male or Female
Do you have any of these conditions: Neuro-Degenerative Disease or Cancer (Pediatric) or Cancer/Tumors or Cancer or Ewing's Family Tumors or Neoplasms?
Do you have any of these conditions: primary malignant neoplasm or malignant tumor or malignancy or Neuro-Degenerative Disease or Cancer (Pediatric) or Cancer or cancers or malignancies o...?
able to give informed consent
age 18-89
Subjectively healthy and, in the opinion of the investigators, likely to be compliant with the drug regimen and the schedule of follow up visits
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, athletic people who are in exceptionally robust condition 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 QT intervals corrected with Fridericia's method (QTcF) of less than 440 mSec
No concurrent medications with the exception of p.r.n. NSAIDS, which must be discontinued one week prior to the lead-in period, and avoided for the next three weeks while on study (the one week lead-in period, one week on drug period, and one week washout period)
Willing and able to refrain from abusing any recreational drugs, including marijuana because of its sleep effects, and drink less than one unit of alcoholic beverages per day starting one week prior to the lead-in period, and avoided for the next three weeks while on study (the one week lead-in period, one week on drug period, and one week washout period)
Willing to refrain from donating blood while during the month of study
Willing to refrain from participating in any other research study that requires taking medication during the month of study
Willing to refrain from being vaccinated during the month of study

Exclusion Criteria

History of allergy to clonidine
History of multiple hypersensitivity reactions, as indicated by allergies to multiple medications, foods, and seasonal pollen
History or physical examination suggestive of a condition, disorder, or disease that could represent a contra-indication to taking an antihypertensive. The relative contraindications to clonidine listed in the package insert under the section on precautions will be exclusionary in this study. They include subjects with coronary artery insufficiency syndromes, histories of myocardial infarction, cardiac conduction abnormalities, cerebrovascular disease, and chronic renal failure
Women who are pregnant or breast feeding will not be eligible to participate in the study, as clonidine is classified as a Class C risk to a fetus. (In fact, there is a safety signal in pregnant animal models that justifies exclusion, even if the signal is weak.)
History or physical examination suggestive of a condition, disorder, or disease that could affect the adsorption, distribution, metabolism or excretion of the study drug
Positive urine toxicology screen for recreational drugs, other than cannabis
History of attention deficit hyperactivity disorder (ADHD) as a child or a residual disorder as an adult, because safety, tolerability, and patient acceptability have already been shown in these populations
Subjects may not be a member of a vulnerable population
May not have taken any controlled medications, including other study drugs, in the last 30 days or for 10 half-lives, whichever is longer
May not have donated blood in the 30 days prior to the start of the lead-in period
May not have participated in research administering drugs in the last 30 days
May not have been vaccinated in the 30 days prior to the start of the lead-in period
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