Healthy AdultNCT07755267
Cutoff Assessment for Codeine in Fingerprint Sweat Relative to Oral Fluid, Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults
An observational study of Healthy Adult, run by Intelligent Bio Solutions Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Determination of codeine phosphate
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2026to 6 Feb 2026
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects will be selected from non-institutionalized persons consisting of members of the community at large.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- Reports a history of smoking within previous six months.
- 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.
- Reports difficulty fasting or consuming standardized meals.
- Demonstrates a positive pregnancy screen (females only).
- If, in the opinion of the Investigator, the subject is not suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The Intelligent Fingerprinting Drug Testing System The Intelligent Fingerprinting Drug Testing System utilizes three components for the qualitative determination of codeine in human fingerprint sweat. It is for in vitro diagnostic use only and intended for prescription use indoors by trained personnel. The intended use environment is an indoor office, or an office-like setting such as a portable or prefabricated cabin. The Intelligent Fingerprinting Drug Screening Cartridge, a single-use, lateral-flow immunoassay cartridge, is intended for use with Intelligent Fingerprinting DSR-Plus fluorescence reader. Directly following completion of collecting a full set of 10 fingerprints, the DSC-7 Drug Screening Cartridge is placed in the DSR-Plus fluorescence reader. This test provides only a preliminary result.
Negative results from the Drug Screening cartridge do not require any additional analysis. Non-negative results must be confirmed with a more specific chemical method by using the Sample Collection Cartridge to collect an additional fingerprint sweat specimen. A validated, traceable liquid chromatography/tandem mass spectrometry (LC/MS-MS) method is preferred.
Subjects must be healthy male and non-pregnant female subjects between ages 18 and 55, inclusive, at the time of dosing. Subject body mass index (BMI) must be between 18.0 kg/m2 to 32.0 kg/m2, inclusive, and total weight must be at least 60 kg.
Subjects will check into the clinic the evening prior to codeine phosphate dosing, at least 14 hours prior to dosing, and remain confined in house until at least 24 hours after the initial codeine phosphate dose.
The total number of healthy adult subjects (male and non-pregnant females) required for enrollment in this study protocol is 40. The total duration of the study, from check-in through the end of the study will be approximately 3 days. Subjects will be confined for at least 24 hours after the first codeine dose. Both 60 mg codeine phosphate doses will be given orally in tablet form with 100-120 mL of room temperature water, followed by two oral rinses (rinse and spit) of 30-50 mL water each. 50 mg of naltrexone hydrochloride will be given as a single oral dose with approximately 120 mL of room temperature water at approximately 12 hours (±30 min) prior to the first administration of codeine, again with breakfast at one hour prior to the first codeine phosphate administration, and again 12 hours (±30 min) after the first codeine dose. Additional dose(s) of naltrexone hydrochloride (1 x 50 mg) may be administered at the discretion of the Investigator
Sampling comprises 13 time points for each of fingerprint sweat and oral fluid per subject for opiate content. Baseline biological fluid sampling (fingerprint sweat and oral fluid) will occur within 90 minutes prior to the codeine dosage, then subsequently at 0.5 hours, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 10.5, 12.5 and 24 hours (±15 min) after the codeine phosphate dose. At each time point, specimens will be collected in the order of fingerprint sweat (screening cartridge), oral fluid, and fingerprint sweat on the Sample Collection Cartridge. A handwash and 15-minute wait (following handwash) will precede both fingerprint sweat specimen collections.
Screening results from both fingerprint sweat specimens and oral fluid will be recorded from instrumentation (DSR-Plus) or visual read (OralTox) within 10 minutes of sampling as either a negative or non-negative result. Quantitative codeine concentrations will be determined for the specimens described above using a validated LC-MS/MS method.
- Conditions
- Healthy Adult
- Being tested
- Determination of codeine phosphate
- Keywords
- drug screening, opiates, fingerprint sweat, non-invasive, codeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of codeine phosphateDevice
Measurement of codeine phosphate in oral fluid and fingerprint sweat of dosed subjects
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 22 subjects Receives: Device: Determination of codeine phosphate | |
| Cohort 2 | 20 subjects Receives: Device: Determination of codeine phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours of codeine dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start28 Jan 2026
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intelligent Bio Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cliantha Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755267
- Sponsor's protocol ID
- IBS-2025-02
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutoff Assessment for Codeine in Fingerprint Sweat Relative to Oral Fluid, Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults
- ClinicalTrials.gov ID
- NCT07755267
- Acronym / sponsor ID
- IBS-2025-02
- Conditions
- Healthy Adult
- Keywords
- drug screening, opiates, fingerprint sweat, non-invasive, codeine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Intelligent Bio Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cliantha Research
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 10 Aug 2026 (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.
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.
Detailed description
The Intelligent Fingerprinting Drug Testing System The Intelligent Fingerprinting Drug Testing System utilizes three components for the qualitative determination of codeine in human fingerprint sweat. It is for in vitro diagnostic use only and intended for prescription use indoors by trained personnel. The intended use environment is an indoor office, or an office-like setting such as a portable or prefabricated cabin. The Intelligent Fingerprinting Drug Screening Cartridge, a single-use, lateral-flow immunoassay cartridge, is intended for use with Intelligent Fingerprinting DSR-Plus fluorescence reader. Directly following completion of collecting a full set of 10 fingerprints, the DSC-7 Drug Screening Cartridge is placed in the DSR-Plus fluorescence reader. This test provides only a preliminary result.
Negative results from the Drug Screening cartridge do not require any additional analysis. Non-negative results must be confirmed with a more specific chemical method by using the Sample Collection Cartridge to collect an additional fingerprint sweat specimen. A validated, traceable liquid chromatography/tandem mass spectrometry (LC/MS-MS) method is preferred.
Subjects must be healthy male and non-pregnant female subjects between ages 18 and 55, inclusive, at the time of dosing. Subject body mass index (BMI) must be between 18.0 kg/m2 to 32.0 kg/m2, inclusive, and total weight must be at least 60 kg.
Subjects will check into the clinic the evening prior to codeine phosphate dosing, at least 14 hours prior to dosing, and remain confined in house until at least 24 hours after the initial codeine phosphate dose.
The total number of healthy adult subjects (male and non-pregnant females) required for enrollment in this study protocol is 40. The total duration of the study, from check-in through the end of the study will be approximately 3 days. Subjects will be confined for at least 24 hours after the first codeine dose. Both 60 mg codeine phosphate doses will be given orally in tablet form with 100-120 mL of room temperature water, followed by two oral rinses (rinse and spit) of 30-50 mL water each. 50 mg of naltrexone hydrochloride will be given as a single oral dose with approximately 120 mL of room temperature water at approximately 12 hours (±30 min) prior to the first administration of codeine, again with breakfast at one hour prior to the first codeine phosphate administration, and again 12 hours (±30 min) after the first codeine dose. Additional dose(s) of naltrexone hydrochloride (1 x 50 mg) may be administered at the discretion of the Investigator
Sampling comprises 13 time points for each of fingerprint sweat and oral fluid per subject for opiate content. Baseline biological fluid sampling (fingerprint sweat and oral fluid) will occur within 90 minutes prior to the codeine dosage, then subsequently at 0.5 hours, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 10.5, 12.5 and 24 hours (±15 min) after the codeine phosphate dose. At each time point, specimens will be collected in the order of fingerprint sweat (screening cartridge), oral fluid, and fingerprint sweat on the Sample Collection Cartridge. A handwash and 15-minute wait (following handwash) will precede both fingerprint sweat specimen collections.
Screening results from both fingerprint sweat specimens and oral fluid will be recorded from instrumentation (DSR-Plus) or visual read (OralTox) within 10 minutes of sampling as either a negative or non-negative result. Quantitative codeine concentrations will be determined for the specimens described above using a validated LC-MS/MS method.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Determination of codeine phosphate22 subjects |
| Cohort 2 | – | Device: Determination of codeine phosphate20 subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects will be selected from non-institutionalized persons consisting of members of the community at large.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| Determination of codeine phosphateMeasurement of codeine phosphate in oral fluid and fingerprint sweat of dosed subjects | Device | Cohort 1, Cohort 2 |
Primary outcome
Fingerprint sweat codeine cutoff
Time frame: Within 24 hours of codeine dosing
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.
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 10 Aug 2026.
- United States Prescribing Information: Codeine Sulfate. Revised Jul 2009. Accessed on 2 October 2025Link provided by the sponsor.
- Product. Intelligent Fingerprinting. Accessed date 2 October 2025Link provided by the sponsor.
- Electronic RxList. Summary of Product Characteristics: Codeine Sulfate. Revised 12 Sep 2023Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult, run by Intelligent Bio Solutions Inc. at 1 site in Canada.
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 8 inclusion and 21 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 10 Aug 2026. 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 Canada. 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.
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?
Fingerprint sweat codeine cutoff (time frame: Within 24 hours of codeine dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.