Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Condition: Device Latency
Intervention: Placebo; Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
Intervention description: Oral placebo-embedded IEM tablet.; Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: OPC-14597 Digital; Aripiprazole; Medical Information Device #1 System (MIND1); Ingestible Event Marker

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.
    

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

          -  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