Feasibility of Administering Clonidine as a Pharmacological Challenge in Imaging Studies

NCT04030572 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 19-04020242
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuro-Degenerative Disease; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of subjects experiencing adverse events related to drug-induced changes in hemodynamic function.

  clinically significant drop in blood pressure or pulse

  Day 2 or Day 8 compared to Day (-7) through Day 1 during drug-free lead-in

Secondary Outcomes (2)

• Change in Total Sleep Duration

  Day 2 and Day 8 on drug and Day 16 washout compared to Day (-7) through Day 1 during drug-free lead-in

• Change in Deep Sleep Time

  Day 2 and Day 8 on drug and Day 16 washout compared to Day (-7) through Day 1 during drug-free lead-in

Study Arms (1)

Clonidine Pill

EXPERIMENTAL

One week period of clonidine, 0.1 mg tabs, one by mouth daily at bedtime

Drug: Clonidine Pill

Interventions

Clonidine Pill DRUG

0.1 mg tabs, one by mouth daily at bedtime for one week

Also known as: On-Drug

Clonidine Pill

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 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• P. David Mozley, MD

  Weill Medical College of Cornell University

  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: July 22, 2019
• First Posted: July 24, 2019
• Study Start: December 10, 2019
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be made available within six months of last study visit or acceptance for publication, whichever comes first.
• Access Criteria: Any reasonable request sent to dvm9029@med.cornell.edu

Locations

US (1)