PET Study of a2a Agonist Effects on the Ventricular CSF Clearance of [11C]Butanol

NCT04032691 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 19-05020048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This investigator initiated, pilot study will assess the feasibility of characterizing the effects of an orally administered alpha-2 adrenergic (a2a) agonist, clonidine, on the clearance rates of Carbon-11 butanol from the ventricular cerebrospinal fluid (vCSF) with positron emission tomography (PET) in healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Clinically significant changes in hemodynamic function, including vital signs (VSs) and ECG parameters, will be classified as adverse events.

  one week on drug

Secondary Outcomes (1)

• Change in Ventricular CSF Clearance Rates of [11C]Butanol

  after one week on drug compared to drug free baseline rates

Other Outcomes (4)

• Sleep Quality: Duration

  Average of one week before drug compared to one week on drug, and one week after drug.

• Sleep Quality: Time in Deep Sleep

  Average of one week before drug compared to one week on drug, and one week after drug.

• Sleep Quality: number of nocturnal awakenings

  Average of one week before drug compared to one week on drug, and one week after drug.

Study Arms (1)

Clonidine Pill

EXPERIMENTAL

0.1 mg by mouth daily at bedtime for one week

Drug: Clonidine Pill

Interventions

Clonidine Pill DRUG

0.1 mg by mouth daily at bedtime for one week

Also known as: On-Drug

Clonidine Pill

Eligibility Criteria

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

You may qualify if:

• Able to give informed consent. No vulnerable populations.
• Age 18-to-89 years old
• Mini-Mental Status Examination of ≥ 28
• Confirmed by the screening procedures to still be reasonably healthy and, in the opinion of the investigators, likely to tolerate the imaging procedures. For example, patients with chronic low back pain might not be able to lie still for very long.
• Confirmed by the screening procedures to have normal hemodynamic function. Systolic blood pressure and pulse must be higher than 120 mmHg and 60 beats per minute (bpm) while sitting. At the discretion of the investigators, athletic people who engage in vigorous exercise of one hour or more at least 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 QT interval corrected with Frederica's method (QTcF) of less than 440 mSec.
• 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 during the month of study (because of its potential effect of quickening pulse).
• 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.
• Have not participated in research with exposure to ionizing radiation that would result in approaching the exposure limits for healthy volunteers described in the Code of Federal Regulations, Title 21 Part 361.1 (21CFR361.1)

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 pollens.
• History, physical examination or clinical laboratory test result suggestive of a condition, disorder, or disease that could affect the adsorption, distribution, metabolism or excretion of clonidine, including an alcohol abuse or dependence disorder.
• Positive urine toxicology screen for drugs other than cannabis.
• Subjects may not be a member of a vulnerable population.
• 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

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 19, 2019
• First Posted: July 25, 2019
• Study Start: August 27, 2019
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Available at end of study (anticipated date = 31 Dec 2020) for up to five years.
• Access Criteria: All investigators who provide a brief statement expressing a scientific interest.

Locations

US (1)