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

September 27, 2021 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
Time Frame: 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.
Up to Hour 6 on Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Latency Period From Ingestion to Detection of IEM
Time Frame: 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.
Day 1 at Hours 0, 2, 4, 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2014

Primary Completion (Actual)

April 18, 2014

Study Completion (Actual)

April 18, 2014

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 316-13-206A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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