Method Comparison of Intelligent Fingerprinting Drug Screening System

Официальное название

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

Обзор

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."

Подробное описание

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. 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 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 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.

Первичные конечные точки

• Sensitivity [Срок оценки: 24 hrs]
• Specificity [Срок оценки: 24 hrs]
• Accuracy [Срок оценки: 24 hrs]

Критерии участия

Критерии включения

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.

Критерии исключения

• Unwilling or unable to provide informed consent.
• 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 a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
• 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.
• Is pregnant (females only).
• Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
• Reports history of respiratory depression (e.g., sleep apnea).
• Reports history of reaction to codeine (e.g., nausea, allergy).
• Current severe hypotension (i.e., systolic blood pressure <90 mmHg).
• Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
• Reports current presence of acute bronchial asthma/ upper airway obstruction.
• Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
• Reports history or current condition of adrenal insufficiency.
• Reports history or current condition of renal disease.
• If, in the opinion of the Investigator, the subject is not suitable for the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• CenExel Clinical Research — Marlton

Идентификаторы

NCT: NCT07650136 · IBS-2025-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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