User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
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."
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Able to provide informed consent
- •Completed the screening process within 30 days prior to dosing.
- •Healthy male and non-pregnant female subjects at the time of dosing.
- •Body mass index (BMI) from 18.0 kg/m2 to 32.0 kg/m2, inclusive
- •Weigh at least 60 kg.
- •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
- •Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments.
排除标准
- •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.
结局指标
主要结局
Sensitivity
时间窗: 24 hrs
Sensitivity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
Specificity
时间窗: 24 hrs
Specificity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
Accuracy
时间窗: 24 hrs
Accuracy of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
次要结局
未报告次要终点