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

NCT02091882 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 316-13-206A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Device Latency

Keywords

OPC-14597 Digital; Aripiprazole; Medical Information Device #1 System (MIND1); Ingestible Event Marker

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Latency Period From Ingestion to Detection of IEM

  Day 1 at Hours 0, 2, 4, 6

Study Arms (1)

Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System

EXPERIMENTAL

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; Combination Product: Combination product of Aripiprazole + IEM + Sensor + MIND1 Application

Interventions

Placebo DRUG

Oral placebo-embedded IEM tablet.

Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System

Combination product of Aripiprazole + IEM + Sensor + MIND1 Application COMBINATION_PRODUCT

Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone

Also known as: Abilify MyCite®

Aripiprazole IEM Tablet + Placebo IEM Tablet + MIND1 System

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

Unknown Facility

Walnut Creek, California, 94598, United States

Location

Related Publications (3)

• 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.

  PMID: 38085556 DERIVED

• Rohatagi S, Profit D, Hatch A, Zhao C, Docherty JP, Peters-Strickland TS. Optimization of a Digital Medicine System in Psychiatry. J Clin Psychiatry. 2016 Sep;77(9):e1101-e1107. doi: 10.4088/JCP.16m10693.

  PMID: 27487251 DERIVED

• Profit D, Rohatagi S, Zhao C, Hatch A, Docherty JP, Peters-Strickland TS. Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period. J Clin Psychiatry. 2016 Sep;77(9):e1095-e1100. doi: 10.4088/JCP.16m10643.

  PMID: 27379966 DERIVED

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

1-609-524-6788

Study Officials

• Study Director

  Otsuka Pharmaceutical Development & Commercialization

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 19, 2014
• Study Start: March 21, 2014
• Primary Completion: April 18, 2014
• Study Completion: April 18, 2014
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (1)