Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351852
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-21
Brief Title:
Transdermal Administration by a Novel Wireless Iontophoresis Device
Sponsor:
James J Peters Veterans Affairs Medical Center
Organization:
James J Peters Veterans Affairs Medical Center
Study Overview
Official Title:
Safety and Pharmacokinetics of Positively Charged Compounds by Transdermal Administration by a Novel Wireless Iontophoresis Device
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Persons with spinal cord injury SCI have neurogenic bowel disorders which is associated with significant morbidity The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI Despite the magnitude of the problem of bowel dysfunction in persons with SCI and the associated reduction in quality of life this condition has yet to be effectively treated The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation BE
The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon as shown by our team of investigators To address this problem a dual medication combination neostigmine and glycopyrrolate was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein intravenously or into the muscle bed intramuscularly Because no one likes needles and because of the practical limits of administering medications on a routine basis by the use of needles especially in persons with SCI because of their other health considerations the investigators have devised a new approach driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel iontophoresis
The proposed research project to determine the safety of positively charged compounds eg vitamin B12 NEO and GLY administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work The ability to use a wireless ION device is far more practical for patients to use especially those with SCI which will permit the self-administration of these agents in the home setting to induce a bowel evacuation
The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon as shown by our team of investigators To address this problem a dual medication combination neostigmine and glycopyrrolate was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein intravenously or into the muscle bed intramuscularly Because no one likes needles and because of the practical limits of administering medications on a routine basis by the use of needles especially in persons with SCI because of their other health considerations the investigators have devised a new approach driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel iontophoresis
The proposed research project to determine the safety of positively charged compounds eg vitamin B12 NEO and GLY administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work The ability to use a wireless ION device is far more practical for patients to use especially those with SCI which will permit the self-administration of these agents in the home setting to induce a bowel evacuation
Detailed Description:
Subject recruitment will be drawn from prior participants in our Centers research studies and the outpatient clinics Subjects will be informed verbally and in writing of the purpose of this study Informed consent will be obtained from all subjects who agree to participate Subjects will be free to withdraw their consent at any time Subject travel costs and a stipend for participation will be provided by the grant DOD CDMRP SC180166 Records will be kept confidential by removing the name of the subject from all data and assigning each subject a random identification number which will be recorded on all subject data sheets and linked by identifiers which are listed in a master key that is appropriately secured An investigator or research coordinator will enroll subjects coordinate blood laboratory studies collect data and coordinate the responsibilities of all study subjects Subjects will be asked to arrive at the Center at the JJP VAMC Room 7A-13 on the day of their appointment A baseline EKG will be obtained to exclude participants with any EKG abnormalities On Day 1 after obtaining subject consent vitamin B12 will be administered transcutaneously via the wireless ION device On Day 2 NEO 007 mgkg and GLY 0014 mgkg will be administered transcutaneously via wired ION device Dynatron iBox On Day 3 NEO 007 mgkg and GLY 0014 mgkg will be administered transcutaneously by a wireless ION device The maximum dose of neostigmine is 10 mg or 007 mgkg whichever is less and the maximum dose of glycopyrrolate is 2 mg or 0014 mgkg All safety end points will also be collected on each day of the study
After NEO and GLY administration heart rate bowel sounds blood pressure oxygen levels and any adverse symptoms will be recorded at times of each blood collection Bowel sounds and evacuation time will also be recorded if each occurs but they are not endpoints of this protocol The subjects will be monitored for a minimum of 120 minutes At least two research personnel will be present during the study visit to record all data and perform the tasks required
After the administration of each agents venous blood 4 ml will be collected into a purple-top tube EDTA tube at baseline 5 10 20 30 40 60 90 and 120 minutes The blood will be placed in an ice bath and centrifuged to separate the formed blood cell elements from plasma The plasma will be aliquoted in equal volume into two vials and labelled with the date protocol number and the subjects unique identifier and timepoint of sample collection The samples will be placed in a -80 degrees Celsius freezer until batch shipped for assay of NEO and of GLY by mass spectroscopy in the SUNY Downstate Albany Research Laboratory by Dr Qishan Lin
After NEO and GLY administration heart rate bowel sounds blood pressure oxygen levels and any adverse symptoms will be recorded at times of each blood collection Bowel sounds and evacuation time will also be recorded if each occurs but they are not endpoints of this protocol The subjects will be monitored for a minimum of 120 minutes At least two research personnel will be present during the study visit to record all data and perform the tasks required
After the administration of each agents venous blood 4 ml will be collected into a purple-top tube EDTA tube at baseline 5 10 20 30 40 60 90 and 120 minutes The blood will be placed in an ice bath and centrifuged to separate the formed blood cell elements from plasma The plasma will be aliquoted in equal volume into two vials and labelled with the date protocol number and the subjects unique identifier and timepoint of sample collection The samples will be placed in a -80 degrees Celsius freezer until batch shipped for assay of NEO and of GLY by mass spectroscopy in the SUNY Downstate Albany Research Laboratory by Dr Qishan Lin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None