Substudy 'B' of the Accuracy of Ingestible Event Marker (... | NCT02404532

NCT02404532

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Device: MIND1 System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MIND1 System	Device	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).

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Timothy Peters-Strickland, MD	Otsuka Pharmaceutical Development & Commercialization, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Walnut Creek	California	94598	United States

PubMed Identifier	Type	Citation	Retractions
38085556	Derived	Jan M, Coppin-Renz A, West R, Gallo CL, Cochran JM, Heumen EV, Fahmy M, Reuteman-Fowler JC. Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials. JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.

Arm/Group Information

ID	Title	Description
FG000	MIND1 System IEM Detection (All Enrolled Participants)	On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device [eg, smart phone] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded ingestible event marker (IEM) tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by the medical information device #1 (MIND1) system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smart phone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smart phone).

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	MIND1 System IEM Detection (All Enrolled Participants)	On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device [eg, smartphone] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smart phone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone).

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.

Posted

Count of Participants

Participants

Day 1 Visit, at hours 0, 2, 4, 6

ID	Title	Description
OG000	MIND1 System IEM Detection (All Enrolled Participants)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MIND1 System IEM Detection (All Enrolled Participants)	On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device [eg, smartphone] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone).