Interference and Stability Evaluation of the Intelligent Fingerprinting Drug Screening System

NCT07758907 | Enrolling By Invitation

• 1 other identifier: IBS-2025-04
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System

Conditions

Interference With Routine Analytical Tests; Stability of in Vitro Diagnostic Reagents; Illicit Drug Use

Keywords

Interference; Stability

Outcome Measures

Primary Outcomes (1)

• Effect of Potential Interferents

  The primary outcome of this study is to understand the impact of potential exogenous interferents on the Intelligent Fingerprinting Drug Screening System. Fluorescence measurement data from the fingerprint sweat screening method, along with LC-MS/MS data, will be analyzed post hoc to determine if any of the potential exogenous interferents has an appreciable effect on system results.

  For exogenous interferent contact within 15 minutes prior to fingerprint sweat specimen collection.

Secondary Outcomes (1)

• Stability of Confirmation Cartridge

  Up to three months following application of fingerprint sweat specimen

Study Arms (2)

Stability

OTHER

20 subjects. The fingerprint sweat sampling sequence for stability evaluation comprises two sequences. Each sequence begins with a codeine dose, an initial hand wash, and a fingerprint sweat specimen collection. The hand wash/sweat collection cycle is repeated three more times. The entire sequence is repeated for eight total specimens.

Device: Device storage condition

Interference

EXPERIMENTAL

75 subjects. Sampling comprises five time points of fingerprint sweat specimen collection for each of two interferents in the undosed conditions, and seven time points of fingerprint sweat specimen collection for each of two interferents in the dosed condition. The protocol allows for four additional sampling points during the dosed state for a total of 24-28 fingerprint sweat specimens. Baseline biological fluid sampling (fingerprint sweat) in the undosed condition will occur at 15-minute intervals following an initial hand wash, with repeat sampling. As in the undosed condition, several of the samples are preceded by the application of an interferent to the fingertips. If the initial screening test generates a non-negative result, continue the sequence of interferent application and fingerprint sweat sampling. If the initial screening test generates a negative result, wait 15 minutes and repeat. If the next screening test generates a negative result, wait 15 minutes and repeat.

Device: Interferent application

Interventions

Device storage condition DEVICE

Device will be stored prior to and following sample collection.

Stability

Interferent application DEVICE

Interferent will be applied to subjects' fingers prior to measurement of drug in fingerprint sweat.

Interference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English.
• Completed the screening process within 60 days prior to dosing. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures provided all the required screening procedures have been performed within 60 days prior to dosing.
• Healthy male and non-pregnant female subjects between ages 18 and 55, inclusive, at the time of dosing.
• Body mass index (BMI) between 18.0 kg/m2 to 35.0 kg/m2, inclusive, and weigh at least 60 kg.
• Judged by the Investigator and/or designee to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments along with oxygen saturation, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, ECG, etc.) can be repeated at the discretion of the Investigator and/or designee and judged to be not clinically significant for study participation. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation.
• Subjects with glomerular filtration rate (GFR) of greater than or equal to 60.

You may not qualify if:

• More than three digits absent from the hands due to congenital or accidental cause(s).
• Reports receiving any investigational drug within 30 days prior to dosing.
• Reports any personal history of substance abuse (including drug/alcohol abuse or addiction) or mental illness (e.g. major depression) within one year prior to screening visit.
• Presence of any clinically significant results from laboratory tests, vital signs assessments, as judged by the Investigator.
• Reports a clinically significant illness during the 30 days prior to dosing (as determined by the Investigator).
• Reports a history of allergic response(s) to opiates or related drugs, or any of the interferents listed in Section 13 of the protocol.
• Reports history of respiratory depression (e.g., sleep apnea).
• Current severe hypotension (i.e., systolic blood pressure \<90 mmHg).
• With the exception of the five smokers (study subjects 90-95, see Appendices A and B of the protocol), reports a history of tobacco use (smoking, chewing, vaping) within previous two weeks.
• Report history/current condition of seizures, increased intracranial pressure, brain tumor, head injuries or impaired consciousness.
• Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
• Unwilling to consume meals provided by the clinical site.
• Demonstrates a positive pregnancy screen (females only).
• Any subject for whom dosing with codeine sulfate as described in this protocol is contraindicated (see Section 9.3.2 and Appendix B of the protocol).
• If, in the opinion of the Investigator, the subject is not suitable for the study.

Sponsors & Collaborators

• Intelligent Bio Solutions Inc.: lead
• CenExel: collaborator

Study Sites (1)

CenExel New Jersey

Marlton, New Jersey, 08053, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 11, 2026
• Study Start: June 15, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)