A Post-market Clinical Follow-up Investigation in Healthy Volunteers Measuring Eye Parameters to Verify Performance and Safety of Previct® Drugs for Monitoring of Patients in Treatment of Substance Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Verify if self-administered eye scanning using a mobile phone application, using native key features (alone or in predefined combination(s)), can indicate use of each medicine (D1-D2).
研究概览
简要总结
This is a post-market clinical follow-up study on an approved CE-marked eHealth system where a mobile phone application is used to measure the pupils and eye measurements to monitor the use of different drug substances. The goal of the study is to collect additional information when using the system and to improve the current models for indicating the use of cannabinoids and phenethylamines.
Drug intake of cannabinoid or phenethylamine will in this study be simulated using two commonly used medicines.
The study will include healthy volunteers where each participant will participate in the study for approximately 10 days. The participant will be using the mobile phone application for about a week, first at the clinic and then in the home environment. After approximately a week the participant will visit the clinic to be administered with the selected medicine whereafter the mobile phone application will be used for up to 5 hours. A final phone call will be taken place at approximately day 10, whereafter the participant has completed the study.
详细描述
This is a controlled, prospective, post-market clinical follow-up study that aims to collect additional data on performance and safety of the CE-marked eHeatlh system Previct Drugs. Previct Drugs is intended to be used in treatment of substance use disorder (SUD) to support and monitor patients' treatment. The system relies on self-administered eye scanning performed with a mobile phone application where the analysis of the eye´s reaction on intake of drug substances gives an indication of different drug substances. The clinical data collected in this study is an important step to verify and improve the algorithms of Previct Drugs, and to improve the mathematical models for indicating the use of the substances cannabinoids and phenethylamines.
Drug intake will in this study be simulated by a controlled single application of commonly used medicines from cannabinoids and phenethylamine.
The study will enroll and follow 30 male and female healthy volunteers for participation of approximately 10 days. The study will consist of two visits to the clinic, and one follow-up telephone call before the participant has completed the study. Baseline data will be collected at the first visit on Day 0, including usage of Previct Drugs, followed by usage of Previct Drugs in the home environment for about one week. At visit 2 on Day 7, the subject will be administered with the medicine he/she has been randomized to and thereafter use Previct Drugs for up to 5 hours. A final follow-up telephone call will take place approximately at day 10 before the participant has completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Male or female healthy volunteers.
- •Age 18 to 55 years.
- •BMI between 18.5-30 kg/m
- •Weight between 50-100 kg.
- •Healthy as determined by the investigator or designee based on pre-investigational medical and surgical history, and health examination at enrollment.
- •Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and at visit 2 and must agree to use a medically acceptable contraception from enrollment until clinical investigation completion.
- •No current drug usage defined as a negative urine drug test at enrollment and at visit
- •Able to use Previct Drugs after initial training (defined as successfully performing a test set after trying maximum three times per measurement).
- •Voluntarily agrees to participate and has duly singed the Informed Consent Form.
排除标准
- •Participating in another clinical investigation which may affect the clinical investigation outcome according to clinical judgement.
- •Previously participated in the KCClin01 investigation.
- •Pregnant or lactating.
- •Blind and/or deaf.
- •Clinically abnormal ECG, according to the investigator. QTcF time above 450 ms at enrollment.
- •Resting heart rate above 90 BPM.
- •Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse.
- •Current or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical judgement.
- •Any disease or condition that may influence pupillary reflexes based on clinical judgement.
- •Undergone eye surgery that may influence pupillary reflexes based on clinical judgement.
- •Ongoing treatment with medications which may interfere with eye measurements based on clinical judgement.
- •Ongoing treatment with medications which may interfere with any of the medicinal products to be used.
- •History or presence of allergy or serious reaction to the medicinal products to be used.
- •History or presence of cardiovascular disease, e.g., arteriosclerosis, hypertension, or cor pulmonale.
- •History or presence of sleep-related breath disorder.
- •History or presence of gastrointestinal disease, e.g., paralytic ileus, acute abdomen, delayed gastric emptying, or chronic constipation.
- •History or presence of pulmonary disease, e.g., acute pulmonary insufficiency, severe respiratory depression with hypoxia, chronic obstructive lung disease, or bronchial asthma.
- •History or presence of autoimmune neuromuscular disease, e.g., myasthenia gravis.
- •Not able to read or understand the local language.
- •Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate.
研究组 & 干预措施
Cannabinoid
A single administration of cannabinoid where a CE-marked eHealth system will be used before and after intake.
干预措施: Measurements with a eHealth system (Device)
Phenethylamine
A single administration of phenethylamine where a CE-marked eHealth system will be used before and after intake.
干预措施: Measurements with a eHealth system (Device)
结局指标
主要结局
Verify if self-administered eye scanning using a mobile phone application, using native key features (alone or in predefined combination(s)), can indicate use of each medicine (D1-D2).
时间窗: Day 7 (+/- 2 days)
For each medicine (D1-D2), changes for each subject in key features (alone or in predefined combination(s)) between baseline at visit 2 and under the influence of D1-D2 at LC-MS/MS defined peak concentration, using native key features. Key feature is defined as a predefined characteristic obtained from an eye measurement such as pupil size or motion of iris position over time.
Verify if Self-administered Eye Scanning Using a Mobile Phone Application, Using Native Key Features (Alone or in Predefined Combination(s)), Can Indicate Use of Each Medicine (D1-D2).
时间窗: Day 7 (+/- 2 days)
For each medicinal product (D1-D2), number of changed key features from baseline to the LC-MS/MS (Liquid Chromatography Tandem Mass-Spectroscopy) verified peak concentration in plasma after administration of medicinal product at visit 2 using native pupillograms. Each of the 21 key features represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and peak concentration is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
次要结局
- Verify if self-administered eye scanning using a mobile phone application, after refinement of the method for establishing key features (alone or in predefined combination(s)), can indicate the use of each medicine (D1-D2).(Day 7 (+/- 2 days))
- Evaluate the first and last time after medicine intake of D1 or D2 when refined key eye features, alone or in predefined combination(s), differ from baseline.(Day 7 (+/- 2 days))
- Evaluate the difference between refined drug naïve test data collected at the clinic and compared with tests performed in home environment.(From Day 0 to Day 7 (+ 2 days))
- Evaluate if the refined drug naïve key features (alone or in predefined combination(s)), collected at baseline differs from data collected at peak plasma concentration under the influence of D1-D2 without compensating for intra-individual variation.(Day 7 (+/- 2 days))
- Verify if Self-administered Eye Scanning Using a Mobile Phone Application, After Refinement of the Method for Establishing Key Features (Alone or in Predefined Combination(s)), Can Indicate the Use of Each Medicine (D1-D2).(Day 7 (+/- 2 days))
- Evaluate the First and Last Measurement Occasion After Medicine Intake of D1 or D2 When Refined Key Eye Features, Alone or in Predefined Combination(s), Differ From Baseline.(Day 7 (+/- 2 days))
- Evaluate the Difference Between Refined Drug naïve Test Data Collected at the Clinic and Compared With Tests Performed in Home Environment.(From Day 0 to Day 7 (+ 2 days))
- Evaluate if the Refined Drug naïve Key Features (Alone or in Predefined Combination(s)), Collected at Baseline Differs From Data Collected at Peak Plasma Concentration Under the Influence of D1-D2 Without Compensating for Intra-individual Variation.(Day 7 (+/- 2 days))
- Incidence and Severity of Adverse Events.(From enrollment until end of follow-up, up to telephone follow-up call latest at Day 14.)