Interference With Routine Analytical TestsNCT07758907
Interference and Stability Evaluation of the Intelligent Fingerprinting Drug Screening System
A study testing Device storage condition and Interferent application in people with Interference With Routine Analytical Tests and Stability of in Vitro Diagnostic Reagents, run by Intelligent Bio Solutions Inc. at 1 site in United States.
Trial summary
Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Interference With Routine Analytical Tests, Stability of in Vitro Diagnostic Reagents, Illicit Drug Use
- What is being tested?
- Device storage condition and Interferent application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
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 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Interference and Stability Evaluation of the Intelligent Fingerprinting(TM) Drug Screening System
Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System
Read the detailed description
95 healthy adults, male and non-pregnant female subjects. Each subject receives two doses of 60mg codeine sulfate in tablet form, the second dose four hours after the first. The first twenty subjects enrolled provide fingerprint sweat specimens for Sample Collection Cartridge stability evaluation. Each of the remaining 75 subjects provides fingerprint sweat specimens for evaluation of interference effects. These 75 subjects handle two interferents prior to providing fingerprint sweat specimens, both before and after receiving the codeine sulfate dose.
- Conditions
- Interference With Routine Analytical Tests, Stability of in Vitro Diagnostic Reagents, Illicit Drug Use
- Being tested
- Device storage condition, Interferent application
- Keywords
- Interference, Stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device storage conditionDevice
Device will be stored prior to and following sample collection.
Interferent applicationDevice
Interferent will be applied to subjects' fingers prior to measurement of drug in fingerprint sweat.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Interferent application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For exogenous interferent contact within 15 minutes prior to fingerprint sweat specimen collection.
Secondary outcomes (1)
Stability of Confirmation Cartridge
Evaluation of the stability of the Sample Collection Cartridge, a component of the Intelligent Fingerprinting Drug Screening System in four aspects: 1) stability prior to fingerprint sweat collection, 2) stability after fingerprint sweat collection, 3) shipping stability prior to fingerprint sweat collection, and 4) shipping stability after fingerprint sweat collection.
Measured: Up to three months following application of fingerprint sweat specimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start15 Jun 2026
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interference With Routine Analytical TestsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intelligent Bio Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CenExel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758907
- Sponsor's protocol ID
- IBS-2025-04
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Proprietary information regarding a non-cleared, non-commercial device
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interference and Stability Evaluation of the Intelligent Fingerprinting(TM) Drug Screening System
- ClinicalTrials.gov ID
- NCT07758907
- Acronym / sponsor ID
- IBS-2025-04
- Conditions
- Interference With Routine Analytical Tests, Stability of in Vitro Diagnostic Reagents, Illicit Drug Use
- Keywords
- Interference, Stability
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Intelligent Bio Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- CenExel
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 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.
Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System
Detailed description
95 healthy adults, male and non-pregnant female subjects. Each subject receives two doses of 60mg codeine sulfate in tablet form, the second dose four hours after the first. The first twenty subjects enrolled provide fingerprint sweat specimens for Sample Collection Cartridge stability evaluation. Each of the remaining 75 subjects provides fingerprint sweat specimens for evaluation of interference effects. These 75 subjects handle two interferents prior to providing fingerprint sweat specimens, both before and after receiving the codeine sulfate dose.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stability | Other | Device: Device storage condition20 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. |
| Interference | Experimental | Device: Interferent application75 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 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.
Key exclusion criteria (15 listed)
- 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).
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 |
|---|---|---|
| Device storage conditionDevice will be stored prior to and following sample collection. | Device | Stability |
| Interferent applicationInterferent will be applied to subjects' fingers prior to measurement of drug in fingerprint sweat. | Device | Interference |
Primary outcome
Effect of Potential Interferents
Time frame: For exogenous interferent contact within 15 minutes prior to fingerprint sweat specimen collection.
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.
1 secondary outcome
Stability of Confirmation Cartridge
Time frame: Up to three months following application of fingerprint sweat specimen
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. Proprietary information regarding a non-cleared, non-commercial device
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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.
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?
A study testing Device storage condition and Interferent application in people with Interference With Routine Analytical Tests and Stability of in Vitro Diagnostic Reagents, run by Intelligent Bio Solutions Inc. at 1 site in United States.
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 6 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 11 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Effect of Potential Interferents (time frame: For exogenous interferent contact within 15 minutes prior to fingerprint sweat specimen collection.). 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 11 Aug 2026.