PharmacokineticsNCT06519045
PK of Codeine and Metabolites in Human Fingerprint Sweat, Oral Fluid, Blood and Urine
An observational study of Pharmacokinetics, run by Intelligent Bio Solutions Inc. at 1 site in Canada.
Trial summary
This study will compare positive and negative test results obtained from fingerprint sweat using the Intelligent Fingerprinting Drug Screening Cartridge, versus opiates in sweat collected via the Fingerprint Collection Kit for Laboratory Analysis, versus blood, oral fluid and urine sample concentrations of opiates… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Intelligent Fingerprinting Drug Screening System
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jun 2024to 30 Sep 2024
- 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
- Adult
Study population: Subjects will be selected from non-institutionalized subjects 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.
- Completed the IRB-approved screening process within 28 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 kg/m2 to 32 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, clinical laboratory assessments, and by general observations.
- 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, and electrocardiograms, as judged by the Investigator.
- Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
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- Reports a clinically significant illness during the 28 days prior to dosing (as determined by the Investigator).
- Reports a history of allergic response(s) to Naltrexone or other opiates/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.
- Demonstrates a positive drug screen for cotinine or history of smoking within previous six months.
- Report history/current condition of seizures, increased intracranial pressure, brain tumor, head injuries or impaired consciousness.
- Reports a blood donation totaling between 101 mL to 499 mL of blood within 30 days prior to dosing or subject who has donated more than 499 mL of blood within 56 days prior to dosing. All subjects will be advised not to donate blood for 30 days after completing the study.
- Reports donating plasma (e.g., plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for 30 days after completing the study.
- Demonstrates, in the opinion of study staff, veins unsuitable for repeated venipuncture (e.g., veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
- 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
Official title: Pharmacokinetic Profiles of Codeine and Metabolites in Fingerprint Sweat, Oral Fluid, Blood and Urine Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults
This study will compare positive and negative test results obtained from fingerprint sweat using the Intelligent Fingerprinting Drug Screening Cartridge, versus opiates in sweat collected via the Fingerprint Collection Kit for Laboratory Analysis, versus blood, oral fluid and urine sample concentrations of opiates identified within codeine phosphate dosed healthy males and non-pregnant females.
- Conditions
- Pharmacokinetics
- Being tested
- Intelligent Fingerprinting Drug Screening System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Fingerprinting Drug Screening SystemDevice
The Intelligent Fingerprinting Drug Screening System utilizes a single-use, rapid, non-invasive fingerprint sweat drug screening test intended for use with the Intelligent Fingerprinting DSR-Plus fluorescence reader. The Intelligent FingerprintingTM Fingerprint Collection Kit for Laboratory Analysis (i.e. confirmation test) provides a quantitative analytical result via laboratory-based liquid chromatography/tandem mass spectrometry (LC-MS/MS). It is used to collect and measure drug mass in the full set of 10 fingerprints.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Dosed with 3x60mg codeine Receives: Device: Intelligent Fingerprinting Drug Screening System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine
Peak concentration in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of specimens
Measured: From -1 hr to 24 hrs relative to codeine sulfate dose
Time to reach maximum concentration (Tmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine
Time after drug administration at which peak plasma concentration occurs in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of specimens
Measured: From -1 hr to 24 hrs relative to codeine sulfate dose
Area under the curve (AUC) of codeine in fingerprint sweat, oral fluid, plasma, and urine
Efficiency of physiological processes that characterize the drug elimination in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
Measured: From -1 hr to 24 hrs relative to codeine sulfate dose
Terminal half-life (T1/2) of codeine in fingerprint sweat, oral fluid, plasma, and urine
The period of time that it takes for the concentration of codeine and codeine-6-glucuronide to decrease by 50% in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
Measured: From -1 hr to 24 hrs relative to codeine sulfate dose
Clearance of codeine in fingerprint sweat, oral fluid, plasma, and urine
Amount of codeine eliminated per unit of time/ drug concentration in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
Measured: From -1 hr to 24 hrs relative to codeine sulfate dose
Secondary outcomes (1)
Sensitivity of fingerprint sweat screening system for codeine
Comparison of results of fingerprint sweat screening system to LC-MS/MS analysis of fingerprint sweat specimens for codeine
Measured: From -1 hr to 24 hrs relative to codeine sulfate dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start11 Jun 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intelligent Bio Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cliantha Research
- Responsible party
- Sponsor
- Investigators
- Philip Mathew, MD, Principal investigator, Cliantha Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519045
- Sponsor's protocol ID
- IBS-2024-01
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Profiles of Codeine and Metabolites in Fingerprint Sweat, Oral Fluid, Blood and Urine Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults
- ClinicalTrials.gov ID
- NCT06519045
- Acronym / sponsor ID
- IBS-2024-01
- Conditions
- Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Intelligent Bio Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cliantha Research
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 Jul 2024 (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 study will compare positive and negative test results obtained from fingerprint sweat using the Intelligent Fingerprinting Drug Screening Cartridge, versus opiates in sweat collected via the Fingerprint Collection Kit for Laboratory Analysis, versus blood, oral fluid and urine sample concentrations of opiates identified within codeine phosphate dosed healthy males and non-pregnant females.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Intelligent Fingerprinting Drug Screening SystemDosed with 3x60mg codeine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Subjects will be selected from non-institutionalized subjects 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.
- Completed the IRB-approved screening process within 28 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 kg/m2 to 32 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, clinical laboratory assessments, and by general observations.
Key exclusion criteria (24 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, and electrocardiograms, 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 |
|---|---|---|
| Intelligent Fingerprinting Drug Screening SystemThe Intelligent Fingerprinting Drug Screening System utilizes a single-use, rapid, non-invasive fingerprint sweat drug screening test intended for use with the Intelligent Fingerprinting DSR-Plus fluorescence reader. The Intelligent FingerprintingTM Fingerprint Collection Kit for Laboratory Analysis (i.e. confirmation test) provides a quantitative analytical result via laboratory-based liquid chromatography/tandem mass spectrometry (LC-MS/MS). It is used to collect and measure drug mass in the full set of 10 fingerprints. | Device | 1 |
Primary outcome
Maximum concentration (Cmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Peak concentration in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of specimens
Time to reach maximum concentration (Tmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Time after drug administration at which peak plasma concentration occurs in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of specimens
Area under the curve (AUC) of codeine in fingerprint sweat, oral fluid, plasma, and urine
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Efficiency of physiological processes that characterize the drug elimination in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
Terminal half-life (T1/2) of codeine in fingerprint sweat, oral fluid, plasma, and urine
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
The period of time that it takes for the concentration of codeine and codeine-6-glucuronide to decrease by 50% in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
Clearance of codeine in fingerprint sweat, oral fluid, plasma, and urine
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Amount of codeine eliminated per unit of time/ drug concentration in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
1 secondary outcome
Sensitivity of fingerprint sweat screening system for codeine
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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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.
Philip Mathew, MD principal investigator
Cliantha Research
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 Pharmacokinetics, 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 24 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. 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?
Results are not available in the source record.
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?
Maximum concentration (Cmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine (time frame: From -1 hr to 24 hrs relative to codeine sulfate dose). The study lists 5 primary outcomes in all. 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 25 Jul 2024.