Trial Outcomes & Findings for Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1) (NCT NCT02091882)
NCT ID: NCT02091882
Last Updated: 2021-10-26
Results Overview
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.
COMPLETED
PHASE4
30 participants
Up to Hour 6 on Day 1
2021-10-26
Participant Flow
This trial was conducted on 30 healthy participants at one trial site in the United States from 21 March 2014 to 18 April 2014.
Participant milestones
| Measure |
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 it was detected by MIND1 System.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Baseline characteristics by cohort
| Measure |
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
n=30 Participants
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.
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|---|---|
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Age, Continuous
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39.8 Years
STANDARD_DEVIATION 15.3 • n=5 Participants
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Sex: Female, Male
Female
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17 Participants
n=5 Participants
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Sex: Female, Male
Male
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13 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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26 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=5 Participants
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Race (NIH/OMB)
White
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16 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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6 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to Hour 6 on Day 1Population: Intention-to-Treat (ITT) Sample included all participants who ingested at least one aripiprazole + IEM tablet, regardless of whether or not ingestion was detected.
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.
Outcome measures
| Measure |
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
n=30 Participants
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 it was detected by MIND1 System.
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|---|---|
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Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
Day 1, Hour 0
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73.3 percentage of participants
Interval 57.0 to 86.0
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Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
Day 1, Hour 2
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63.3 percentage of participants
Interval 46.7 to 77.9
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Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
Day 1, Hour 4
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76.7 percentage of participants
Interval 60.6 to 88.5
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Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
Day 1, Hour 6
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93.3 percentage of participants
Interval 80.5 to 98.8
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SECONDARY outcome
Timeframe: Day 1 at Hours 0, 2, 4, 6Population: 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.
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.
Outcome measures
| Measure |
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
n=30 Participants
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 it was detected by MIND1 System.
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|---|---|
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Latency Period From Ingestion to Detection of IEM
Day 1, Hour 0
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4 minutes
Interval 1.0 to 14.0
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Latency Period From Ingestion to Detection of IEM
Day 1, Hour 2
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1 minutes
Interval 0.0 to 3.0
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Latency Period From Ingestion to Detection of IEM
Day 1, Hour 4
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1 minutes
Interval 0.0 to 2.0
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Latency Period From Ingestion to Detection of IEM
Day 1, Hour 6
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1 minutes
Interval 0.0 to 4.0
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Adverse Events
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
n=30 participants at risk
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 it was detected by MIND1 System.
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|---|---|
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Gastrointestinal disorders
Nausea
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16.7%
5/30 • From Day 1 to 2-week safety follow up (Day 15)
Safety Sample included all participants who ingested at least one aripiprazole + IEM tablet or IEM tablet or placebo + IEM tablet.
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Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
- Publication restrictions are in place
Restriction type: OTHER