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

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02091882
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 32.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Device Latency	Drug: Placebo; Combination Product: Combination product of Aripiprazole + IEM + Sensor + MIND1 Application	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: OSMITTER 316-13-206A 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
• Actual Study Start Date: Mar 21, 2014
• Actual Primary Completion Date: Apr 18, 2014
• Actual Study Completion Date: Apr 18, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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 detected by MIND1 System.

Drug: Placebo; Oral placebo-embedded IEM tablet.; Combination Product: Combination product of Aripiprazole + IEM + Sensor + MIND1 Application; Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone; Other Names: Abilify MyCite®

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Walnut Creek	California	United States	94598

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

• Study Director: Study Director, Otsuka Pharmaceutical Development & Commercialization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT02091882
• Other Study ID Numbers: 316-13-206A
• First Posted: Mar 19, 2014
• Last Update Posted: Oct 26, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.: OPC-14597 Digital; Aripiprazole; Medical Information Device #1 System (MIND1); Ingestible Event Marker
• Additional relevant MeSH terms: Aripiprazole

Study Results

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.

Arm/Group Title	Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Arm/Group Description	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.
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Arm/Group Description	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.
Overall Participants	30
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39.8 (15.3)
Sex: Female, Male (Count of Participants)
Female	17 56.7%
Male	13 43.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 13.3%
Not Hispanic or Latino	26 86.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 13.3%
Native Hawaiian or Other Pacific Islander	1 3.3%
Black or African American	3 10%
White	16 53.3%
More than one race	0 0%
Unknown or Not Reported	6 20%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Arm/Group Description	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.
Measure Participants	30
Day 1, Hour 0	73.3 244.3%
Day 1, Hour 2	63.3 211%
Day 1, Hour 4	76.7 255.7%
Day 1, Hour 6	93.3 311%

2. Secondary Outcome

Title	Latency Period From Ingestion to Detection of IEM
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Arm/Group Description	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.
Measure Participants	30
Day 1, Hour 0	4
Day 1, Hour 2	1
Day 1, Hour 4	1
Day 1, Hour 6	1

Adverse Events

Time Frame	From Day 1 to 2-week safety follow up (Day 15)
Adverse Event Reporting Description	Safety Sample included all participants who ingested at least one aripiprazole + IEM tablet or IEM tablet or placebo + IEM tablet.
Arm/Group Title	Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
Arm/Group Description	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.
All Cause Mortality
	Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System
	Affected / at Risk (%)	# Events
Total	5/30 (16.7%)
Gastrointestinal disorders
Nausea	5/30 (16.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.