Clinical trial NCT02091882: Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Device Latency
Keywords: OPC-14597 Digital
Aripiprazole
Medical Information Device #1 System (MIND1)
Ingestible Event Marker
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
timeFrame: Up to Hour 6 on Day 1
Secondary outcomes:
measure: Latency Period From Ingestion to Detection of IEM
timeFrame: Day 1 at Hours 0, 2, 4, 6
Other outcomes:
Locations:
city: Walnut Creek
country: United States
state: California
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.