Device Latency
Conditions
Keywords
OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Ingestible Event Marker
Brief summary
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
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.
Interventions
DEVICEMIND1 System
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).
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 Visit, at hours 0, 2, 4, 6 | 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. |
| Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch | Day 1 Visit at 0, 2, 4 and 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Day 1 Visit at 0, 2, 4 and 6 hours | 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 |
| Number of Participants With AEs Due Study Treatment and MIND1 System | At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit) | 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. |
Countries
United States
Participant flow
Recruitment details
This sub-study was conducted on 29 healthy male and female participants at a single site (clinic) in United States (US). All enrolled participants received study treatment for 1 day (Visit 1), plus a 1-week (7 \[+1\] days after the last trial visit) safety follow-up period (via phone call).
Pre-assignment details
A screening period of 14 days included various procedures such as informed consent form signing, urine pregnancy test, study eligibility review, vital signs measurement, medical history, concomitant medication, baseline & demographic data collection, physical measurement, drugs of abuse test & any adverse events (AEs) assessments.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | MIND1 System IEM Detection (All Enrolled Participants) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 43.0 years STANDARD_DEVIATION 15.2 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
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.
Time frame: Day 1 Visit, at hours 0, 2, 4, 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIND1 System IEM Detection (All Enrolled Participants) | 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 | Hour 0 | 28 Participants |
| MIND1 System IEM Detection (All Enrolled Participants) | 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 | Hour 2 | 27 Participants |
| MIND1 System IEM Detection (All Enrolled Participants) | 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 | Hour 4 | 28 Participants |
| MIND1 System IEM Detection (All Enrolled Participants) | 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 | Hour 6 | 29 Participants |
Primary
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.
Time frame: Day 1 Visit at 0, 2, 4 and 6 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIND1 System IEM Detection (All Enrolled Participants) | Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch | Hour 0 | 1.2 Minutes | Standard Deviation 0.8 |
| MIND1 System IEM Detection (All Enrolled Participants) | Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch | Hour 2 | 1.3 Minutes | Standard Deviation 1 |
| MIND1 System IEM Detection (All Enrolled Participants) | Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch | Hour 4 | 1.1 Minutes | Standard Deviation 1.3 |
| MIND1 System IEM Detection (All Enrolled Participants) | Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch | Hour 6 | 1.3 Minutes | Standard Deviation 0.9 |
Secondary
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.
Time frame: At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)
Population: The Safety sample included all participants who had ingested at least 1 dose of a placebo-embedded IEM, which was the same as the ITT dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIND1 System IEM Detection (All Enrolled Participants) | Number of Participants With AEs Due Study Treatment and MIND1 System | All Treatment-Emergent Adverse Events (TEAEs) | 0 participants |
| MIND1 System IEM Detection (All Enrolled Participants) | Number of Participants With AEs Due Study Treatment and MIND1 System | Treatment-Emergent Serious AEs | 0 participants |
| MIND1 System IEM Detection (All Enrolled Participants) | Number of Participants With AEs Due Study Treatment and MIND1 System | Serious Related TEAEs | 0 participants |
| MIND1 System IEM Detection (All Enrolled Participants) | Number of Participants With AEs Due Study Treatment and MIND1 System | TEAEs led to discontinuation | 0 participants |
| MIND1 System IEM Detection (All Enrolled Participants) | Number of Participants With AEs Due Study Treatment and MIND1 System | Number of death | 0 participants |
Secondary
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
Time frame: Day 1 Visit at 0, 2, 4 and 6 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIND1 System IEM Detection (All Enrolled Participants) | 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). | Hour 0 | 5.59 Minutes | Standard Deviation 23.07 |
| MIND1 System IEM Detection (All Enrolled Participants) | 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). | Hour 2 | 9.74 Minutes | Standard Deviation 21.16 |
| MIND1 System IEM Detection (All Enrolled Participants) | 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). | Hour 4 | 3.58 Minutes | Standard Deviation 7.84 |
| MIND1 System IEM Detection (All Enrolled Participants) | 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). | Hour 6 | 4.00 Minutes | Standard Deviation 7.14 |
| MDDS to Otsuka Software Application Registration | 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). | Hour 2 | 0.52 Minutes | Standard Deviation 0.7 |
| MDDS to Otsuka Software Application Registration | 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). | Hour 4 | 2.62 Minutes | Standard Deviation 7.48 |
| MDDS to Otsuka Software Application Registration | 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). | Hour 6 | 2.21 Minutes | Standard Deviation 6.6 |
| MDDS to Otsuka Software Application Registration | 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). | Hour 0 | 1.85 Minutes | Standard Deviation 6.38 |
| Otsuka Software Application Registration to Cloud Server | 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). | Hour 4 | 0.01 Minutes | Standard Deviation 0.01 |
| Otsuka Software Application Registration to Cloud Server | 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). | Hour 2 | 0.02 Minutes | Standard Deviation 0.01 |
| Otsuka Software Application Registration to Cloud Server | 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). | Hour 6 | 0.01 Minutes | Standard Deviation 0.01 |
| Otsuka Software Application Registration to Cloud Server | 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). | Hour 0 | 0.01 Minutes | Standard Deviation 0.01 |
| Patch Acquisition of IEM to Cloud Server | 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). | Hour 6 | 6.21 Minutes | Standard Deviation 8.91 |
| Patch Acquisition of IEM to Cloud Server | 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). | Hour 2 | 10.28 Minutes | Standard Deviation 20.93 |
| Patch Acquisition of IEM to Cloud Server | 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). | Hour 0 | 7.46 Minutes | Standard Deviation 23.67 |
| Patch Acquisition of IEM to Cloud Server | 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). | Hour 4 | 6.21 Minutes | Standard Deviation 10.36 |