Method Comparison of Intelligent Fingerprinting Drug Screening System

NCT07650136 | Recruiting FDA Device

• 1 other identifier: IBS-2025-03
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multi-site, open-label, single- or double-dose, randomized, multi-site performance evaluation of accuracy of the Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."

Conditions

In Vitro Diagnostic Device

Outcome Measures

Primary Outcomes (3)

• Sensitivity

  Sensitivity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine

  24 hrs

• Specificity

  Specificity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine

  24 hrs

• Accuracy

  Accuracy of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine

  24 hrs

Study Arms (2)

Undosed

No codeine administered

Device: Diagnostic Test

Dosed

2 doses of codeine administered in tablet form, 60 mg per dose

Device: Diagnostic Test

Interventions

Diagnostic Test DEVICE

Measurement of codeine in human fingerprint sweat

Dosed; Undosed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

135 "donors" and nine "operators." "Operators" represent end users who utilize the screening system in an office or work setting. These subjects do not have to possess special training in laboratory methods. "Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening. Sufficient numbers of subjects will be screened to attain those numbers and to ensure that at least 33% of each sex and at least 15% Black subjects are included as "donors" in the study. At least two sites will have both sexes represented among "operator" subjects. Sites may recruit sufficient alternate subjects to ensure achievement of those numbers. Subjects will be selected from members of the community at large.

You may qualify if:

• \. Able to provide informed consent 2. Completed the screening process within 30 days prior to dosing. 3. Healthy male and non-pregnant female subjects at the time of dosing. 4. Body mass index (BMI) from 18.0 kg/m2 to 32.0 kg/m2, inclusive 5. Weigh at least 60 kg. 5. Females of childbearing potential must be willing to practice an acceptable form of contraception, and have a negative urine pregnancy test on admission to the treatment phase of the study.
• \. Males must agree to practice an acceptable form of contraception 7. Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments.

You may not qualify if:

• Unwilling or unable to provide informed consent.
• 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 a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
• 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.
• Is pregnant (females only).
• Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
• Reports history of respiratory depression (e.g., sleep apnea).
• Reports history of reaction to codeine (e.g., nausea, allergy).
• Current severe hypotension (i.e., systolic blood pressure \<90 mmHg).
• Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
• Reports current presence of acute bronchial asthma/ upper airway obstruction.
• Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
• Reports history or current condition of adrenal insufficiency.
• Reports history or current condition of renal disease.

Sponsors & Collaborators

• Intelligent Bio Solutions Inc.: lead

Study Sites (1)

CenExel Clinical Research

Marlton, New Jersey, 08053, United States

RECRUITING

MeSH Terms

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Elan Cohen, PhD

CONTACT

856.452.9901; e.cohen@cenexel.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: June 2, 2026
• Primary Completion: July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

US (1)