OSMITTER 316-13-206A Substudy: A Substudy to Measure the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1) System and Determine the Latency Period
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
研究概览
简要总结
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
详细描述
The OSMITTER study protocol was designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy was conducted to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Healthy males or healthy non-pregnant females 18 to 65 years of age at the time of informed consent who are willing to either practice abstinence or 2 barrier methods of birth control or 1 barrier method and an oral contraceptive method
- •Participants must be in good general health (not suffering from a serious chronic mental or physical disorder that has required or may in the near future require urgent medical care)
- •Body mass index between 19 to 32 kg/m^2
- •Ability to eat the high-fat meal
排除标准
- •Participants with a history of skin sensitivity to adhesive medical tape or metals
- •Participants who, in the opinion of the investigator, is acutely psychotic or manic and has symptoms currently requiring hospitalization
- •Participants with a history or evidence of a medical condition that would expose him or her to an undue risk of a significant adverse event (AE) or interfere with assessments of safety during the course of the trial
- •Participants have received any investigational product within the last 30 days.
- •Participants has a current history of drug or alcohol dependence that meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
- •Participants has the presence of cognitive impairment
- •Participants currently taking antipsychotic medication
- •Participants with a terminal illness
- •Participants with a history of chronic dermatitis
- •Participants with a history of gastrointestinal surgery that could impair absorption
- •Female participants who are breastfeeding and/or who have a positive serum pregnancy test result prior to receiving trial medications
- •Sexually active women of childbearing potential (WOCBP) who will not commit to using 2 forms of approved birth control methods or who will not remain abstinent during this trial and for 30 days following the last dose of trial medication
- •Sexually active males who will not commit to using 2 of the approved birth control methods or who will not remain abstinent for the duration of the trial and for 90 days following the last dose of trial medication
- •No permanent physical residence
- •After resting for ≥3 minutes, have a sitting systolic blood pressure <100 or ≥150 millimeters of mercury (mmHg) and/or diastolic blood pressure <50 or ≥90 mmHg
- •After resting for ≥3 minutes, have a sitting pulse rate <35 or >100 beats per minute
- •Participants who, in the opinion of the investigator, should not participate in the trial
研究组 & 干预措施
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Participants were placed a patch by the clinical staff prior to each ingestible event marker (IEM) tablet ingestion. Participants received one IEM tablet approximately every 2 hours, for a total of 4 ingestions on Day 1 at 0, 2, 4 and 6 hours.
Following placement of the patch by clinic staff, participants ingested one 10 mg aripiprazole-embedded IEM tablet without food at Hour 0, one placebo-embedded IEM tablet without food at approximately Hour 2, one placebo-embedded IEM tablet with a high fat meal at approximately Hour 4, and one placebo-embedded IEM tablet without food at approximately Hour 6. Clinic staff recorded the time of each ingestion of an IEM and the time detected by MIND1 System.
干预措施: Placebo (Drug)
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Participants were placed a patch by the clinical staff prior to each ingestible event marker (IEM) tablet ingestion. Participants received one IEM tablet approximately every 2 hours, for a total of 4 ingestions on Day 1 at 0, 2, 4 and 6 hours.
Following placement of the patch by clinic staff, participants ingested one 10 mg aripiprazole-embedded IEM tablet without food at Hour 0, one placebo-embedded IEM tablet without food at approximately Hour 2, one placebo-embedded IEM tablet with a high fat meal at approximately Hour 4, and one placebo-embedded IEM tablet without food at approximately Hour 6. Clinic staff recorded the time of each ingestion of an IEM and the time detected by MIND1 System.
干预措施: Combination product of Aripiprazole + IEM + Sensor + MIND1 Application (Combination Product)
结局指标
主要结局
Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
时间窗: Up to Hour 6 on Day 1
The accuracy of IEM signal detection was collected by comparing the time of ingestion recorded by MIND1 system at different timepoints with the time recorded by the clinic staff. The percentage of participants with the accurate time of IEM detection are reported for each ingestion separately at Hours 0, 2, 4 and 6 on Day 1.
次要结局
- Latency Period From Ingestion to Detection of IEM(Day 1 at Hours 0, 2, 4, 6)