Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Condition: Device Latency
Intervention: MIND1 System
Intervention description: 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).
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 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.
    

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.