Spinal Cord InjuriesEarly Phase 1NCT04027972
Pharmacokinetics of Neostigmine and Glycopyrrolate
A Early Phase 1 study testing Combination of Neostigmine and Glycopyrrolate and I-Box by Dynatronics in people with Spinal Cord Injuries and Constipation, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Constipation, Fecal Incontinence
- What is being tested?
- Combination of Neostigmine and Glycopyrrolate and I-Box by Dynatronics
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 20 Dec 2022
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Age 18-70 years
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: Pharmacokinetics of Neostigmine and Glycopyrrolate After Intravenous and Transcutaneous Administration by Iontophoresis
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.
Read the detailed description
The maximum dose of NEO is limited to 10.0 mg and the dose of GLY to 2.0 mg per subject per administration. Subjects will be asked to arrive at the Spinal Cord Research Center at the JJP VAMC (Room 7A-13) on the day of their appointment. On Day 1, following the obtainment the subject's consent, filling out a MoCA cognitive assessment and establishing an IV access point, administration of the medications via IV will be performed. The study design will consist of a Day 1 visit to determine the pharmacokinetic profiles of the IV doses of NEO and GLY. During the second visit, at least 24 hours later, NEO (0.07 mg/kg) and GLY (0.014 mg/kg), applied separately to two patches, will be simultaneously delivered by transdermal administration by ION for 20 minutes. During the third and final visit, at least 24 hours following the second visit, a single patch containing 0.07 mg/kg of NEO and 0.014 mg/kg of GLY will be applied to the skin and delivered by transdermal administration by ION for 20 minutes..
Heart rate, bowel sounds, blood pressure and symptoms will be recorded at 0, 2, 4, 7, 10, 20, 40, 60 minutes of the initiation of the IV push and at 0, 10, 20, 40 and 60 minutes after the initiation of ION. Bowel evacuation time and time after the completion of delivery (by either ION or IV) will be recorded throughout the study visit, as described in Table 2. The subject will assume his/her normal bowel evacuation (BE) position until a bowel movement occurs; privacy draping and privacy will be provided at the time of BE. The subjects will be monitored for a minimum of 60 minutes. A minimum of two research personnel will be present during the study visit to record all of data and perform the tasks required.
After the start a 30 second IV push of NEO which will be followed by a NS flush (12 mL), and then a 30 second IV push of GLY which will be followed by a NS flush (12 mL), venous blood (2 mL) will be drawn into a gold-topped vial at 2, 4, 7, 10, 20, 40 and 60 minutes. Identical technique blood draws will be performed at 10, 20, 30, 40 and 60 minutes after the start of ION. Upon drawing, the blood will be placed in an ice bath and spun using a cooled centrifuge within 5 minutes of collection. Upon completion of 5 minutes of centrifugation, the resulting serum will be aliquoted into two separate vials, with equal volumes and labelled with date, time of draw, associated procedure, NEO or GLY testing destination and the subject's unique identifier. The transfer vials will be inserted into dry ice for at least 10 minutes, after which they will be placed into the -80 degrees Celsius freezer. Plasma levels of NEO and of GLY will be batched and measured at a later date. A file designating the tubes with random numbers associated with the draw times will be created for each subject to conceal the sequence of draw and to attempt the removal of possible bias during the measurement and recording of the concentrations of NEO and GLY (SUNY Downstate Albany Research Laboratory using GE LC-MRM detector).
Proposed Doses:
Day 1: 0.02 mg/kg NEO and 0.004 mg/kg GLY via IV
Day 2: 0.07 mg/kg NEO and 0.014 mg/kg GLY via ION (Two patch administration)
Day 3: 0.07 mg/kg NEO and 0.014 mg/kg GLY via ION (One patch administration)
- Being tested
- Combination of Neostigmine and Glycopyrrolate, I-Box by Dynatronics
- Keywords
- Neostigmine, Glycopyrrolate, Transdermal, Intravenous, Pharmacokinetic, Constipation, Bowel Control, Mass Spectroscopy, Stool Incontinence
- Medical subject headings
- Spinal Cord Injuries, Constipation, Fecal Incontinence, Neurogenic Bowel, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Neostigmine and GlycopyrrolateDrug
Intravenous or transdermal
I-Box by DynatronicsDevice
Also called Iontophoresis
Electric field conducting drugs through the skin without compromising its integrity
| Study group | Role | What they receive |
|---|---|---|
| Primary | Experimental | 6 Subjects will receive all 4 types of medication administration in random sequence Receives: Drug: Combination of Neostigmine and Glycopyrrolate; Device: I-Box by Dynatronics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of Neostigmine and Glycopyrrolate within 1 hour post-administration
Measurement of serum concentration of Neostigmine and of Glycopyrrolate to determine pharmacokinetic profiles
Measured: Within Two Hours
Secondary outcomes (1)
Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps.
Determining safety of drug via presence or absence of headache, dry mouth, muscle twitching, and abdominal cramps as reported by the subjects
Measured: Within 1 hour of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start9 Mar 2020
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Same group receives all 2 treatments but in a randomized order after the IV phase.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Chris Cardozo, James J. Peters Veterans Affairs Medical Center
- Investigators
- Christopher P Cardozo, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027972
- Sponsor's protocol ID
- KOR-18-16
- Status last verified
- Sep 2025
- First submitted
- 19 Jul 2019
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Korsten MA, Lyons BL, Radulovic M, Cummings TM, Sikka G, Singh K, Hobson JC, Sabiev A, Spungen AM, Bauman WA. Delivery of neostigmine and glycopyrrolate by iontophoresis: a nonrandomized study in individuals with spinal cord injury. Spinal Cord. 2018 Mar;56(3):212-217. doi: 10.1038/s41393-017-0018-2. Epub 2017 Nov 8.
PubMed 29116244Korsten MA, Rosman AS, Ng A, Cavusoglu E, Spungen AM, Radulovic M, Wecht J, Bauman WA. Infusion of neostigmine-glycopyrrolate for bowel evacuation in persons with spinal cord injury. Am J Gastroenterol. 2005 Jul;100(7):1560-5. doi: 10.1111/j.1572-0241.2005.41587.x.
PubMed 15984982Chang JY, Locke GR 3rd, McNally MA, Halder SL, Schleck CD, Zinsmeister AR, Talley NJ. Impact of functional gastrointestinal disorders on survival in the community. Am J Gastroenterol. 2010 Apr;105(4):822-32. doi: 10.1038/ajg.2010.40. Epub 2010 Feb 16.
PubMed 20160713Sabiev A, Korsten MA, Bauman WA (2021) A Comparison among Three Skin Preparations for the Transdermal Delivery of Vitamin B12 by Iontophoresis: A Novel Approach to Determine Systemic Absorption. J Pharm Drug Deliv Res 10:3.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Neostigmine and Glycopyrrolate After Intravenous and Transcutaneous Administration by Iontophoresis
- ClinicalTrials.gov ID
- NCT04027972
- Acronym / sponsor ID
- KOR-18-16
- Keywords
- Neostigmine, Glycopyrrolate, Transdermal, Intravenous, Pharmacokinetic, Constipation, Bowel Control, Mass Spectroscopy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 22 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.
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.
Detailed description
The maximum dose of NEO is limited to 10.0 mg and the dose of GLY to 2.0 mg per subject per administration. Subjects will be asked to arrive at the Spinal Cord Research Center at the JJP VAMC (Room 7A-13) on the day of their appointment. On Day 1, following the obtainment the subject's consent, filling out a MoCA cognitive assessment and establishing an IV access point, administration of the medications via IV will be performed. The study design will consist of a Day 1 visit to determine the pharmacokinetic profiles of the IV doses of NEO and GLY. During the second visit, at least 24 hours later, NEO (0.07 mg/kg) and GLY (0.014 mg/kg), applied separately to two patches, will be simultaneously delivered by transdermal administration by ION for 20 minutes. During the third and final visit, at least 24 hours following the second visit, a single patch containing 0.07 mg/kg of NEO and 0.014 mg/kg of GLY will be applied to the skin and delivered by transdermal administration by ION for 20 minutes..
Heart rate, bowel sounds, blood pressure and symptoms will be recorded at 0, 2, 4, 7, 10, 20, 40, 60 minutes of the initiation of the IV push and at 0, 10, 20, 40 and 60 minutes after the initiation of ION. Bowel evacuation time and time after the completion of delivery (by either ION or IV) will be recorded throughout the study visit, as described in Table 2. The subject will assume his/her normal bowel evacuation (BE) position until a bowel movement occurs; privacy draping and privacy will be provided at the time of BE. The subjects will be monitored for a minimum of 60 minutes. A minimum of two research personnel will be present during the study visit to record all of data and perform the tasks required.
After the start a 30 second IV push of NEO which will be followed by a NS flush (12 mL), and then a 30 second IV push of GLY which will be followed by a NS flush (12 mL), venous blood (2 mL) will be drawn into a gold-topped vial at 2, 4, 7, 10, 20, 40 and 60 minutes. Identical technique blood draws will be performed at 10, 20, 30, 40 and 60 minutes after the start of ION. Upon drawing, the blood will be placed in an ice bath and spun using a cooled centrifuge within 5 minutes of collection. Upon completion of 5 minutes of centrifugation, the resulting serum will be aliquoted into two separate vials, with equal volumes and labelled with date, time of draw, associated procedure, NEO or GLY testing destination and the subject's unique identifier. The transfer vials will be inserted into dry ice for at least 10 minutes, after which they will be placed into the -80 degrees Celsius freezer. Plasma levels of NEO and of GLY will be batched and measured at a later date. A file designating the tubes with random numbers associated with the draw times will be created for each subject to conceal the sequence of draw and to attempt the removal of possible bias during the measurement and recording of the concentrations of NEO and GLY (SUNY Downstate Albany Research Laboratory using GE LC-MRM detector).
Proposed Doses:
Day 1: 0.02 mg/kg NEO and 0.004 mg/kg GLY via IV
Day 2: 0.07 mg/kg NEO and 0.014 mg/kg GLY via ION (Two patch administration)
Day 3: 0.07 mg/kg NEO and 0.014 mg/kg GLY via ION (One patch administration)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Same group receives all 2 treatments but in a randomized order after the IV phase.
| Arm | Type | Receives |
|---|---|---|
| Primary | Experimental | Drug: Combination of Neostigmine and Glycopyrrolate, Device: I-Box by Dynatronics6 Subjects will receive all 4 types of medication administration in random sequence |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female
- Age 18-70 years
Key exclusion criteria (16 listed)
- 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,
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 |
|---|---|---|
| Combination of Neostigmine and GlycopyrrolateIntravenous or transdermal | Drug | Primary |
| I-Box by DynatronicsAlso: IontophoresisElectric field conducting drugs through the skin without compromising its integrity | Device | Primary |
Primary outcome
Serum concentrations of Neostigmine and Glycopyrrolate within 1 hour post-administration
Time frame: Within Two Hours
Measurement of serum concentration of Neostigmine and of Glycopyrrolate to determine pharmacokinetic profiles
1 secondary outcome
Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps.
Time frame: Within 1 hour of administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 29116244Korsten MA, Lyons BL, Radulovic M, Cummings TM, Sikka G, Singh K, Hobson JC, Sabiev A, Spungen AM, Bauman WA. Delivery of neostigmine and glycopyrrolate by iontophoresis: a nonrandomized study in individuals with spinal cord injury. Spinal Cord. 2018 Mar;56(3):212-217. doi: 10.1038/s41393-017-0018-2. Epub 2017 Nov 8.
- Background: PubMed 15984982Korsten MA, Rosman AS, Ng A, Cavusoglu E, Spungen AM, Radulovic M, Wecht J, Bauman WA. Infusion of neostigmine-glycopyrrolate for bowel evacuation in persons with spinal cord injury. Am J Gastroenterol. 2005 Jul;100(7):1560-5. doi: 10.1111/j.1572-0241.2005.41587.x.
- Background: PubMed 20160713Chang JY, Locke GR 3rd, McNally MA, Halder SL, Schleck CD, Zinsmeister AR, Talley NJ. Impact of functional gastrointestinal disorders on survival in the community. Am J Gastroenterol. 2010 Apr;105(4):822-32. doi: 10.1038/ajg.2010.40. Epub 2010 Feb 16.
- BackgroundSabiev A, Korsten MA, Bauman WA (2021) A Comparison among Three Skin Preparations for the Transdermal Delivery of Vitamin B12 by Iontophoresis: A Novel Approach to Determine Systemic Absorption. J Pharm Drug Deliv Res 10:3.
- Individual participant dataSharing planned: No
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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.
Christopher P Cardozo, MD principal investigator
James J. Peters Veterans Affairs Medical Center
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 Combination of Neostigmine and Glycopyrrolate and I-Box by Dynatronics in people with Spinal Cord Injuries and Constipation, run by James J. Peters Veterans Affairs Medical Center 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 2 inclusion and 16 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: finished, as of the sponsor's last update on 17 Sep 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum concentrations of Neostigmine and Glycopyrrolate within 1 hour post-administration (time frame: Within Two Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027972, which also lists 4 linked publications.
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 17 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.