Device Latency
Conditions
Keywords
OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Ingestible Event Marker
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Oral placebo-embedded IEM tablet.
COMBINATION_PRODUCTCombination product of Aripiprazole + IEM + Sensor + MIND1 Application
Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on 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 * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Latency Period From Ingestion to Detection of IEM | Day 1 at Hours 0, 2, 4, 6 | Latency period was defined as the time in minutes from the IEM ingestion for both aripiprazole and placebo to the time of detection of IEM by MIND1 system on a smartphone. The latency period is calculated as the difference in the time recorded by the clinic staff of IEM ingestion and the time displayed on the MIND1 application. |
Countries
United States
Participant flow
Recruitment details
This trial was conducted on 30 healthy participants at one trial site in the United States from 21 March 2014 to 18 April 2014.
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System Participants were placed a patch by the clinical staff prior to each 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 it was detected by MIND1 System. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System |
|---|---|
| Age, Continuous | 39.8 Years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 5 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
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.
Time frame: Up to Hour 6 on Day 1
Population: Intention-to-Treat (ITT) Sample included all participants who ingested at least one aripiprazole + IEM tablet, regardless of whether or not ingestion was detected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System | Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection | Day 1, Hour 0 | 73.3 percentage of participants |
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System | Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection | Day 1, Hour 2 | 63.3 percentage of participants |
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System | Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection | Day 1, Hour 4 | 76.7 percentage of participants |
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System | Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection | Day 1, Hour 6 | 93.3 percentage of participants |
Secondary
Latency Period From Ingestion to Detection of IEM
Latency period was defined as the time in minutes from the IEM ingestion for both aripiprazole and placebo to the time of detection of IEM by MIND1 system on a smartphone. The latency period is calculated as the difference in the time recorded by the clinic staff of IEM ingestion and the time displayed on the MIND1 application.
Time frame: Day 1 at Hours 0, 2, 4, 6
Population: ITT Sample included all participants who ingested at least one aripiprazole + IEM tablet, regardless of whether or not ingestion was detected. Number analyzed is the number of participants with data available at specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System | Latency Period From Ingestion to Detection of IEM | Day 1, Hour 0 | 4 minutes |
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System | Latency Period From Ingestion to Detection of IEM | Day 1, Hour 2 | 1 minutes |
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System | Latency Period From Ingestion to Detection of IEM | Day 1, Hour 4 | 1 minutes |
| Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System | Latency Period From Ingestion to Detection of IEM | Day 1, Hour 6 | 1 minutes |