NCT04030572

Feasibility of Administering Clonidine as a Pharmacological Challenge in Imaging Studies

Pilot Study to Assess the Safety, Tolerability, and Feasibility of Administering Clonidine as a Pharmacological Challenge in Future Imaging Studies of Cerebrospinal Fluid Kinetics

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neuro-Degenerative Disease
• Cancer

Interventions

Type	Name	Description
DRUG	Clonidine Pill	0.1 mg tabs, one by mouth daily at bedtime for one week

Timeline

• Start date: 2019-12-10
• Primary completion: 2020-03-17
• Completion: 2020-03-17
• First posted: 2019-07-24
• Last updated: 2021-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study