Interference and Stability Evaluation of the Intelligent Fingerprinting(TM) Drug Screening System
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Effect of Potential Interferents
研究概览
简要总结
Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
- •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.
- •Report history/current condition of seizures, increased intracranial pressure, brain tumor, head injuries or impaired consciousness.
- •Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
- •Unwilling to consume meals provided by the clinical site.
- •Demonstrates a positive pregnancy screen (females only).
- •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).
- •If, in the opinion of the Investigator, the subject is not suitable for the study.
研究组 & 干预措施
Stability
20 subjects. The fingerprint sweat sampling sequence for stability evaluation comprises two sequences. Each sequence begins with a codeine dose, an initial hand wash, and a fingerprint sweat specimen collection. The hand wash/sweat collection cycle is repeated three more times. The entire sequence is repeated for eight total specimens.
干预措施: Device storage condition (Device)
Interference
75 subjects. Sampling comprises five time points of fingerprint sweat specimen collection for each of two interferents in the undosed conditions, and seven time points of fingerprint sweat specimen collection for each of two interferents in the dosed condition. The protocol allows for four additional sampling points during the dosed state for a total of 24-28 fingerprint sweat specimens.
Baseline biological fluid sampling (fingerprint sweat) in the undosed condition will occur at 15-minute intervals following an initial hand wash, with repeat sampling. As in the undosed condition, several of the samples are preceded by the application of an interferent to the fingertips. If the initial screening test generates a non-negative result, continue the sequence of interferent application and fingerprint sweat sampling. If the initial screening test generates a negative result, wait 15 minutes and repeat. If the next screening test generates a negative result, wait 15 minutes and repeat.
干预措施: Interferent application (Device)
结局指标
主要结局
Effect of Potential Interferents
时间窗: 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.
次要结局
- Stability of Confirmation Cartridge(Up to three months following application of fingerprint sweat specimen)