| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuro-Degenerative Disease Cancer | Drug: Clonidine Pill | Early Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 12 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Pilot Study to Assess the Safety, Tolerability, and Feasibility of Administering Clonidine as a Pharmacological Challenge in Future Imaging Studies of Cerebrospinal Fluid Kinetics |
| Actual Study Start Date : | December 10, 2019 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Clonidine Pill
One week period of clonidine, 0.1 mg tabs, one by mouth daily at bedtime
|
Drug: Clonidine Pill
0.1 mg tabs, one by mouth daily at bedtime for one week
Other Name: On-Drug
|
| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Contact: P. David Mozley, MD | 212 746 5805 | dvm9029@med.cornell.edu | |
| Contact: Weill Medical College of Cornell University | 646 962 8200 | jcto@med.cornell.edu |
| United States, New York | |
| Weill Cornell Medicine | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: P. David Mozley, MD 212-746-5805 dvm9029@med.cornell.edu | |
| Principal Investigator: | P. David Mozley, MD | Weill Medical College of Cornell University |
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 22, 2019 | ||||||||||||
| First Posted Date ICMJE | July 24, 2019 | ||||||||||||
| Last Update Posted Date | August 25, 2020 | ||||||||||||
| Actual Study Start Date ICMJE | December 10, 2019 | ||||||||||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Number of subjects experiencing adverse events related to drug-induced changes in hemodynamic function. [ Time Frame: Day 2 or Day 8 compared to Day (-7) through Day 1 during drug-free lead-in ] clinically significant drop in blood pressure or pulse
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | |||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Feasibility of Administering Clonidine as a Pharmacological Challenge in Imaging Studies | ||||||||||||
| Official Title ICMJE | Pilot Study to Assess the Safety, Tolerability, and Feasibility of Administering Clonidine as a Pharmacological Challenge in Future Imaging Studies of Cerebrospinal Fluid Kinetics | ||||||||||||
| 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. | ||||||||||||
| Detailed 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. |
||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase ICMJE | Early Phase 1 | ||||||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE |
|
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| Intervention ICMJE | Drug: Clonidine Pill
0.1 mg tabs, one by mouth daily at bedtime for one week
Other Name: On-Drug
|
||||||||||||
| Study Arms ICMJE | Experimental: Clonidine Pill
One week period of clonidine, 0.1 mg tabs, one by mouth daily at bedtime
Intervention: Drug: Clonidine Pill
|
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| Publications * | Not Provided | ||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE |
12 | ||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
||||||||||||
| Ages ICMJE | 18 Years to 89 Years (Adult, Older Adult) | ||||||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||||||||||
| Removed Location Countries | |||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT04030572 | ||||||||||||
| Other Study ID Numbers ICMJE | 19-04020242 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Weill Medical College of Cornell University | ||||||||||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| PRS Account | Weill Medical College of Cornell University | ||||||||||||
| Verification Date | August 2020 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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