Illicit Drug Use, Interference With Routine Analytical Tests, Stability of in Vitro Diagnostic Reagents
Conditions
Keywords
Interference, Stability
Brief summary
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.
Interventions
DEVICEDevice storage condition
Device will be stored prior to and following sample collection.
DEVICEInterferent application
Interferent will be applied to subjects' fingers prior to measurement of drug in fingerprint sweat.
Sponsors
Intelligent Bio Solutions Inc.
CenExel
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English. 2. 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. 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 18.0 kg/m2 to 35.0 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 (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. 6. Subjects with glomerular filtration rate (GFR) of greater than or equal to 60.
Exclusion criteria
1. More than three digits absent from the hands due to congenital or accidental cause(s). 2. Reports receiving any investigational drug 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. Presence of any clinically significant results from laboratory tests, vital signs assessments, as judged by the Investigator. 5. Reports a clinically significant illness during the 30 days prior to dosing (as determined by the Investigator). 6. Reports a history of allergic response(s) to opiates or related drugs, or any of the interferents listed in Section 13 of the protocol. 7. Reports history of respiratory depression (e.g., sleep apnea). 8. Current severe hypotension (i.e., systolic blood pressure \<90 mmHg). 9. 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. 10. Report history/current condition of seizures, increased intracranial pressure, brain tumor, head injuries or impaired consciousness. 11. Reports known or suspected gastrointestinal obstruction including, paralytic ileus. 12. Unwilling to consume meals provided by the clinical site. 13. Demonstrates a positive pregnancy screen (females only). 14. 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). 15. If, in the opinion of the Investigator, the subject is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Potential Interferents | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stability of Confirmation Cartridge | Up to three months following application of fingerprint sweat specimen | 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. |
Countries
United States
Outcome results
None listed