Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)

Study Overview
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Brief Summary
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The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.

Detailed Description
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The OSMITTER study protocol is designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy is being 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. Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Approximately 30 healthy volunteer subjects will be enrolled in the substudy. The duration of this substudy from Visit 1 (Day 1) to safety follow-up will be approximately 1 week, of which approximately 1 day will be allotted for active subject participation, plus a 1-week safety follow-up period.

Official Title
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OSMITTER 316-13-206B 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

Conditions
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Device Latency

Intervention / Treatment
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* Device: MIND1 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subject 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/m2 (inclusive). Exclusion Criteria: Subject with a history of skin sensitivity to adhesive medical tape or metals. Subject 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. Subject has received any investigational product within the last 30 days. Subject 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. Subject has the presence of cognitive impairment. Subject currently taking antipsychotic medication. Subject with a terminal illness. Subject with a history of chronic dermatitis. Subject with a history of gastrointestinal surgery that could impair absorption. Female subject who is breastfeeding and/or who has 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. A diastolic blood pressure reading >95 mm Hg or symptomatic hypotension. Any subject who, in the opinion of the investigator, should not participate in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: MIND1 System<br>* Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Subjects may eat as they wish over the course of the day. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Clinic staff will record the time of each ingestion of an IEM. Clinic staff will check the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and will record the time it is detected by the MIND1 System compatible computing device (eg, smartphone).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Placebo-embedded IEM Detection by the MIND1 System Measured by the Percentage of Participants With IEM Detection Reported for Each of the 4 Time Points | All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the accuracy of IEM detection by the MIND1 System using the placebo + IEM by the proportion of participants with IEM detection reported for each of the 4 time points. | Day 1 Visit, at hours 0, 2, 4, 6 | 
| Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch | All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To evaluate the latency period between site-reported ingestion time and detection of the ingestion event by the patch which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline. | Day 1 Visit at 0, 2, 4 and 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Latency Period Between the Patch Detection of an Ingestion Event (eg, the Acquisition Time Stamp) and the Detection of the Ingestion Event in the Otsuka Cloud Server (eg, Server Time Stamp). | All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the latency period between the patch detection of an ingestion event and the detection of the ingestion event on the Otsuka Cloud Server which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline ingestion tile after each scheduled ingestion event. The various information transmissions measured were patch Acquisition of IEM to Medical Device Data Systems (MDDS), MDDS to Otsuka software application registration, Otsuka software application registration to Cloud Server and patch Acquisition of IEM to Cloud Server | Day 1 Visit at 0, 2, 4 and 6 hours | 
| Number of Participants With AEs Due Study Treatment and MIND1 System | Safety and tolerability of the system components was assessed by the device-related AEs, non-serious AEs (NSAEs), serious AEs (SAEs), AEs leading to discontinuation, and unanticipated adverse device effects. | At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Ingestible Event Marker