PK of Codeine and Metabolites in Human Fingerprint Sweat, Oral Fluid, Blood and Urine

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pharmacokinetics
• Intervention / Treatment: Device: Intelligent Fingerprinting Drug Screening System

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W1N2
      • Cliantha Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing.
2. Completed the IRB-approved screening process within 28 days prior to dosing.
3. Healthy male and non-pregnant female subjects between ages 18 and 55, inclusive, at the time of dosing.
4. Body mass index (BMI) between 18 kg/m2 to 32 kg/m2, inclusive, and weigh at least 60 kg.
5. 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.
6. Subjects with glomerular filtration rate (GFR) of greater than or equal to 60.
7. 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.
8. Males must agree to practice an acceptable form of contraception.

Exclusion Criteria:

1. More than three digits absent from the hands due to congenital or accidental cause(s).
2. Reports receiving any investigational drug/product within 30 days prior to dosing.
3. 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.
4. 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.
5. Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the Investigator.
6. Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
7. Reports a clinically significant illness during the 28 days prior to dosing (as determined by the Investigator).
8. Reports a history of allergic response(s) to Naltrexone or other opiates/related drugs.
9. Reports hypersensitivity to bisulfites.
10. Reports history of respiratory depression (e.g., sleep apnea).
11. Current severe hypotension (i.e., systolic blood pressure <90 mmHg).
12. Reports current presence of acute bronchial asthma/ upper airway obstruction.
13. If subject reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
14. Reports history/current condition of adrenal insufficiency.
15. Reports history/current condition of renal disease.
16. Demonstrates a positive drug screen for cotinine or history of smoking within previous six months.
17. Report history/current condition of seizures, increased intracranial pressure, brain tumor, head injuries or impaired consciousness.
18. 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.
19. 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.
20. 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).
21. Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
22. Reports difficulty fasting or consuming standardized meals.
23. Demonstrates a positive pregnancy screen (females only).
24. If, in the opinion of the Investigator, the subject is not suitable for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

1; Dosed with 3x60mg codeine

Device: Intelligent Fingerprinting Drug Screening System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	From -1 hr to 24 hrs relative to codeine sulfate dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From -1 hr to 24 hrs relative to codeine sulfate dose

Collaborators and Investigators

• Sponsor: Intelligent Bio Solutions Inc.
• Collaborators: Cliantha Research
• Investigators: Principal Investigator: Philip Mathew, MD, Cliantha Research

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IBS-2024-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No