Healthy VolunteersEarly Phase 1NCT04032691
PET Study of a2a Agonist Effects on the Ventricular CSF Clearance of [11C]Butanol
A Early Phase 1 study testing Clonidine Pill in people with Healthy Volunteers, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Clonidine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2019to 24 May 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- History of allergy to clonidine.
- History of multiple hypersensitivity reactions, as indicated by allergies to multiple medications, foods, and seasonal pollens.
- 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, 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Alpha-2 Adrenergic Receptor Modulation on Rates of Carbon-11 Butanol Clearance From Ventricular Cerebrospinal Fluid
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.
Read the detailed description
This will be an open label pilot study of feasibility in healthy volunteers with no therapeutic intent. Vital signs, electrocardiogram (ECG) parameters, and sleep quality will be measured repeatedly during a one week lead-in period. Then, the ventricular cerebrospinal fluid (vCSF) clearance rates of [11C]butanol will be measured with PET before and after one week of treatment with clonidine, 0.1 mg by mouth daily at bedtime. Safety surveillance will be augmented with home health monitoring devices that are wifi and blue tooth enabled. Surveillance for adverse events related to drug discontinuation will be monitored for one week during a washout period.
Primary Objective: To assess the logistical feasibility and safety of treating normotensive adults with clonidine and monitoring its effects with home health devices. The primary outcome measure will be the number of adverse events (AEs) or serious adverse events (SAEs). Other measures will include changes in sleep quality, vital signs and ECG parameters, such as the PR and corrected QT intervals.
Secondary Objectives: To estimate drug-induced changes in vCSF clearance rates of butanol with PET scans acquired before and after treatment as a function of steady-state plasma levels of clonidine.
- Conditions
- Healthy Volunteers
- Being tested
- Clonidine Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine PillDrug
Also called On-Drug
0.1 mg by mouth daily at bedtime for one week
| Study group | Role | What they receive |
|---|---|---|
| Clonidine Pill | Experimental | 0.1 mg by mouth daily at bedtime for one week Receives: Drug: Clonidine Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Clinically significant changes in hemodynamic function, including vital signs (VSs) and ECG parameters, will be classified as adverse events.
Measured: one week on drug
Secondary outcomes (1)
Change in Ventricular CSF Clearance Rates of [11C]Butanol
The rate of change in the concentration of radioactivity as a function of time before drug treatment compared to after drug treatment.
Measured: after one week on drug compared to drug free baseline rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start27 Aug 2019
- Primary completion24 May 2021
- Study completion24 May 2021
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- P. David Mozley, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032691
- Sponsor's protocol ID
- 19-05020048
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The safety data will be shared. Data will be from the lead-in period, the on-drug period, and the washout period. Safety data include vital signs, electrocardiogram parameters, and quality of sleep measures.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Alpha-2 Adrenergic Receptor Modulation on Rates of Carbon-11 Butanol Clearance From Ventricular Cerebrospinal Fluid
- ClinicalTrials.gov ID
- NCT04032691
- Acronym / sponsor ID
- 19-05020048
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be an open label pilot study of feasibility in healthy volunteers with no therapeutic intent. Vital signs, electrocardiogram (ECG) parameters, and sleep quality will be measured repeatedly during a one week lead-in period. Then, the ventricular cerebrospinal fluid (vCSF) clearance rates of [11C]butanol will be measured with PET before and after one week of treatment with clonidine, 0.1 mg by mouth daily at bedtime. Safety surveillance will be augmented with home health monitoring devices that are wifi and blue tooth enabled. Surveillance for adverse events related to drug discontinuation will be monitored for one week during a washout period.
Primary Objective: To assess the logistical feasibility and safety of treating normotensive adults with clonidine and monitoring its effects with home health devices. The primary outcome measure will be the number of adverse events (AEs) or serious adverse events (SAEs). Other measures will include changes in sleep quality, vital signs and ECG parameters, such as the PR and corrected QT intervals.
Secondary Objectives: To estimate drug-induced changes in vCSF clearance rates of butanol with PET scans acquired before and after treatment as a function of steady-state plasma levels of clonidine.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clonidine Pill | Experimental | Drug: Clonidine Pill0.1 mg by mouth daily at bedtime for one week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- History of allergy to clonidine.
- History of multiple hypersensitivity reactions, as indicated by allergies to multiple medications, foods, and seasonal pollens.
- 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, 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine PillAlso: On-Drug0.1 mg by mouth daily at bedtime for one week | Drug | Clonidine Pill |
Primary outcome
Number of Adverse Events
Time frame: one week on drug
Clinically significant changes in hemodynamic function, including vital signs (VSs) and ECG parameters, will be classified as adverse events.
1 secondary outcome
Change in Ventricular CSF Clearance Rates of [11C]Butanol
Time frame: after one week on drug compared to drug free baseline rates
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: Yes. The safety data will be shared. Data will be from the lead-in period, the on-drug period, and the washout period. Safety data include vital signs, electrocardiogram parameters, and quality of sleep measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P. David Mozley, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Clonidine Pill in people with Healthy Volunteers, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: one week on drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.