CompletedEarly Phase 1

Pharmacokinetics of Neostigmine and Glycopyrrolate

United States13 participantsStarted 2020-03-09

Plain-language summary

A group of 6 able-bodied healthy volunteers will receive Neostigmine (NEO) and Glycopyrrolate (GLY) intravenously and via 2 methods of Iontophoresis (ION): one-patch and two-patch administration, with subsequent blood draws over 1 hour in order to measure the pharmacokinetic behavior of the drugs in-vivo.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or Female * Age 18-70 years Exclusion Criteria: * Previous adverse reaction or hypersensitivity to electrical stimulation, * Known sensitivity to neostigmine or glycopyrrolate, * History of mechanical obstruction of the GI or urinary tract, * Myocardial infarction within 6 months of trial, * Malignant and/or Uncontrollable Hypertension Defined by a blood pressure reading of 160/100 mmHg or higher with or without taking 3 or more different classes of anti-hypertensive medications, * Organ damage (heart \& kidney) and/or TIA-CVA as a result of hypertension, * Known past history of coronary artery disease or bradyarrhythmia, * Symptomatic orthostatic hypotension * Deep brain stimulation * Pregnancy (women who are sexually active and of childbearing potential must utilize a method of contraception and agree to maintain a contraceptive method until completion of the study), * Lactating, nursing females * Inability to provide informed consent signaled by MoCA cognitive test score of 20 or less, * History of ingrown hair folliculitis, * Concurrent illness and fever, * Concurrent participation in a research study, * VA employee.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum concentrations of Neostigmine and Glycopyrrolate within 1 hour post-administration

Timeframe: Within Two Hours

Trial details

NCT IDNCT04027972

SponsorJames J. Peters Veterans Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2022-12-20

View on ClinicalTrials.gov More Spinal Cord Injuries trials