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

Phase 4

Completed

• Conditions: Device Latency
• Interventions: Drug: Placebo; Combination Product: Combination product of Aripiprazole + IEM + Sensor + MIND1 Application

• Registration Number: NCT02091882
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-19
• Study Start: 2014-03-21
• Primary Completion: 2014-04-18
• Study Completion: 2014-04-18
• Disposition First Submitted: 2015-03-25
• Disposition First Submitted QC: 2015-03-25
• Disposition First Posted: 2015-04-15
• Status Verified: 2021-09
• Results First Submitted: 2021-09-27
• Results First Submitted QC: 2021-09-27
• Last Update Submitted: 2021-09-27
• Results First Posted: 2021-10-26
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System	Placebo	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.
Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System	Combination product of Aripiprazole + IEM + Sensor + MIND1 Application	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.