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Method Comparison of Intelligent Fingerprinting Drug Screening System

10. juni 2026 opdateret af: Intelligent Bio Solutions Inc.

User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison

Prospective, multi-site, open-label, single- or double-dose, randomized, multi-site performance evaluation of accuracy of the Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."

Studieoversigt

Status

Rekruttering

Intervention / Behandling

Detaljeret beskrivelse

This will be a study under non-fasting conditions. The total number of healthy adult "operator" subjects (male and non-pregnant females) required for enrollment in this study protocol is nine (9). The total number of healthy adult "donor" subjects (male and non-pregnant females) required for enrollment in this study protocol is 135. These subjects will be distributed across three sites with the recruiting goal of three (3) operators and 45 subjects per site.

Subjects will be recruited to participate as either "operator" or "donor." The total duration of the study, from check-in through the end of the study will be approximately three (3) days for "operators" with no overnight confinement, and one to eight hours for "donors" at two of the sites. At the third site, 31 "donors" will be dosed twice and will remain at the clinic overnight so that biological sampling can occur 24 hours after the first codeine dose. Because the "operators" are required to be at the clinic for three days, they may be recruited separately and compensated at a different rate than the "donors." "Operators" may be employed by the clinic.

"Donors" at sites 1 and 2 will be block randomized to one of two cohorts: no codeine dose or 60 mg codeine dose. The goal is to complete the study with approximately 69% of subjects in the 60 mg cohort. "Donors" at site 3 will be randomized into one of two cohorts: no codeine dose or two 60 mg doses. The cohort receiving two 60 mg codeine doses will be confined at the clinic overnight to enable additional biological sampling events.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

144

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • New Jersey
      • Marlton, New Jersey, Forenede Stater, 08053
        • Rekruttering
        • CenExel Clinical Research
        • Kontakt:
          • Elan Cohen, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

135 "donors" and nine "operators." "Operators" represent end users who utilize the screening system in an office or work setting. These subjects do not have to possess special training in laboratory methods. "Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening.

Sufficient numbers of subjects will be screened to attain those numbers and to ensure that at least 33% of each sex and at least 15% Black subjects are included as "donors" in the study. At least two sites will have both sexes represented among "operator" subjects. Sites may recruit sufficient alternate subjects to ensure achievement of those numbers.

Subjects will be selected from members of the community at large.

Beskrivelse

Inclusion Criteria:

1. Able to provide informed consent 2. Completed the screening process within 30 days prior to dosing. 3. Healthy male and non-pregnant female subjects at the time of dosing. 4. Body mass index (BMI) from 18.0 kg/m2 to 32.0 kg/m2, inclusive 5. Weigh at least 60 kg. 5. Females of childbearing potential must be willing to practice an acceptable form of contraception, and have a negative urine pregnancy test on admission to the treatment phase of the study.

6. Males must agree to practice an acceptable form of contraception 7. Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments.

Exclusion Criteria:

  1. Unwilling or unable to provide informed consent.
  2. More than three digits absent from the hands due to congenital or accidental cause(s).
  3. Reports receiving any investigational drug within 30 days prior to dosing.
  4. Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
  5. 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.
  6. Is pregnant (females only).
  7. Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
  8. Reports history of respiratory depression (e.g., sleep apnea).
  9. Reports history of reaction to codeine (e.g., nausea, allergy).
  10. Current severe hypotension (i.e., systolic blood pressure <90 mmHg).
  11. Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
  12. Reports current presence of acute bronchial asthma/ upper airway obstruction.
  13. Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
  14. Reports history or current condition of adrenal insufficiency.
  15. Reports history or current condition of renal disease.
  16. If, in the opinion of the Investigator, the subject is not suitable for the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Undosed
No codeine administered
Measurement of codeine in human fingerprint sweat
Dosed
2 doses of codeine administered in tablet form, 60 mg per dose
Measurement of codeine in human fingerprint sweat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity
Tidsramme: 24 hrs
Sensitivity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
24 hrs
Specificity
Tidsramme: 24 hrs
Specificity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
24 hrs
Accuracy
Tidsramme: 24 hrs
Accuracy of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
24 hrs

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. juni 2026

Primær færdiggørelse (Anslået)

31. juli 2026

Studieafslutning (Anslået)

31. august 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IBS-2025-03

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med Diagnostic Test

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