Pharmacokinetics of Neostigmine and Glycopyrrolate

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Treatments: Glycopyrrolate; Neostigmine

Criteria

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.