Conditions: Device Latency
Keywords: OPC-14597 Digital Aripiprazole Medical Information Device #1 System (MIND1) Ingestible Event Marker
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: yes

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.

Arms:
arm 1: 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.

Interventions: intervention 1: Placebo intervention 2: Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
Intervention descriptions: intervention 1: Oral placebo-embedded IEM tablet. intervention 2: Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone

Protocol document: