Cutoff Assessment for Codeine in Fingerprint Sweat Relative to Oral Fluid, Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults

NCT07755267 | Completed FDA Device

• 1 other identifier: IBS-2025-02
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, open-label, single-site, in-clinic study with two 20-subject cohorts. Each subject receives two (2) doses of 60mg codeine phosphate in tablet form, the second dose four (4) hours after the first. The primary objective of this study is to compare data from a fingerprint sweat opiate fluorescence immunoassay screening method to oral fluid opiate screening in subjects dosed with codeine phosphate. Fluorescence measurement data from the fingerprint sweat screening method will be analyzed post hoc to select the fingerprint sweat codeine cutoff best aligned with the oral fluid cutoff. The secondary objective is to compare LC-MS/MS data from fingerprint sweat specimens and oral fluid in order to select the fingerprint sweat codeine cutoff best aligned with codeine in oral fluid.

Conditions

Healthy Adult

Keywords

drug screening; opiates; fingerprint sweat; non-invasive; codeine

Outcome Measures

Primary Outcomes (1)

• Fingerprint sweat codeine cutoff

  Fluorescence measurement data from the fingerprint sweat screening method will be analyzed post hoc to select the fingerprint sweat codeine cutoff best aligned with the oral fluid cutoff.

  Within 24 hours of codeine dosing

Study Arms (2)

Cohort 1

22 subjects

Device: Determination of codeine phosphate

Cohort 2

20 subjects

Device: Determination of codeine phosphate

Interventions

Determination of codeine phosphate DEVICE

Measurement of codeine phosphate in oral fluid and fingerprint sweat of dosed subjects

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Male Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from non-institutionalized persons consisting of members of the community at large.

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 30 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 30 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 32.0 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.
• Females of childbearing potential must be willing to practice an acceptable form of contraception, and have a negative serum pregnancy test at screening and a negative urine pregnancy test on admission to the treatment phase of the study.
• Males must agree to practice an acceptable form of contraception.

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/product 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.
• Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the Investigator.
• Presence of any clinically significant results from laboratory tests, vital signs assessments, as judged by the Investigator.
• Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
• 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, naltrexone or related drugs.
• Reports hypersensitivity to bisulfites.
• Reports history of respiratory depression (e.g., sleep apnea).
• Current severe hypotension (i.e., systolic blood pressure \<90 mmHg).
• Reports current presence of acute bronchial asthma/ upper airway obstruction.
• If subject reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
• Reports history/current condition of adrenal insufficiency.
• Reports history/current condition of renal disease.

Sponsors & Collaborators

• Intelligent Bio Solutions Inc.: lead
• Cliantha Research: collaborator

Study Sites (1)

Cliantha Research

Mississauga, Ontario, L4W 1V7, Canada

Location

Related Links

• United States Prescribing Information: Codeine Sulfate. Revised Jul 2009. Accessed on 2 October 2025
• Product. Intelligent Fingerprinting. Accessed date 2 October 2025
• Electronic RxList. Summary of Product Characteristics: Codeine Sulfate. Revised 12 Sep 2023

Study Design

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

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: January 28, 2026
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)