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

NCT ID: NCT02404532

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-03-31

Brief Summary

The purpose of this study is 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 is designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy is being 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. Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions.

Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Approximately 30 healthy volunteer subjects will be enrolled in the substudy. The duration of this substudy from Visit 1 (Day 1) to safety follow-up will be approximately 1 week, of which approximately 1 day will be allotted for active subject participation, plus a 1-week safety follow-up period.

Conditions

Device Latency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

MIND1 System

Intervention Type: DEVICE

Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Subjects may eat as they wish over the course of the day. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Clinic staff will record the time of each ingestion of an IEM. Clinic staff will check the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and will record the time it is detected by the MIND1 System compatible computing device (eg, smartphone).

Interventions

MIND1 System

Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Subjects may eat as they wish over the course of the day. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Clinic staff will record the time of each ingestion of an IEM. Clinic staff will check the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and will record the time it is detected by the MIND1 System compatible computing device (eg, smartphone).

Intervention Type: DEVICE

Eligibility Criteria

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.
• Subject 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/m2 (inclusive).

Exclusion Criteria

• Subject with a history of skin sensitivity to adhesive medical tape or metals.
• Subject 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.
• Subject has received any investigational product within the last 30 days.
• Subject 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.
• Subject has the presence of cognitive impairment.
• Subject currently taking antipsychotic medication.
• Subject with a terminal illness.
• Subject with a history of chronic dermatitis.
• Subject with a history of gastrointestinal surgery that could impair absorption.
• Female subject who is breastfeeding and/or who has 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.
• A diastolic blood pressure reading >95 mm Hg or symptomatic hypotension.
• Any subject who, in the opinion of the investigator, should not participate in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Peters-Strickland, MD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

Walnut Creek, California, United States

Countries

United States

References

Jan M, Coppin-Renz A, West R, Gallo CL, Cochran JM, Heumen EV, Fahmy M, Reuteman-Fowler JC. Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials. JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.

Reference Type: DERIVED

PMID: 38085556 (View on PubMed)

Other Identifiers

316-13-206B

Identifier Type: -

Identifier Source: org_study_id