Interference and Stability Evaluation of the Intelligent Fingerprinting Drug Screening System (NCT07758907) | Clinical Trial Compass
By InvitationNot Applicable
Interference and Stability Evaluation of the Intelligent Fingerprinting Drug Screening System
United States95 participantsStarted 2026-06-15
Plain-language summary
Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of Potential Interferents
Timeframe: For exogenous interferent contact within 15 minutes prior to fingerprint sweat specimen collection.
. 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.
. Reports history of respiratory depression (e.g., sleep apnea).
. Current severe hypotension (i.e., systolic blood pressure \<90 mmHg).