A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion

An Open-label, Prospective Trial Assessing Positive Detection Accuracy and Detection Latency Measures of the Miniature Ingestible Event Marker Tablet Using the D-Tect Patch in Healthy Subjects and Assessing Detection Latency Measures Using the D-Tect Patch in Subjects With Serious Mental Illness Taking Abilify MyCite Tablet

The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Major Depressive Disorder; Mental Disorder; Bipolar I Disorder
• Intervention / Treatment: Drug: Placebo IEM tablet; Drug: Abilify MyCite®; Device: D-Tect Patch

Detailed Description

This is an open-label study to determine the accuracy of ingestible event marker (IEM) detection and detection latency of the D-Tect patch by completing a series of patch applications and IEM ingestions in the clinic.

The participants were enrolled in two cohorts within this study- Cohort 1: healthy participants received the placebo-embedded IEM tablets, Cohort 2: participants with serious mental illness (SMI) i.e schizophrenia, major depressive disorder, or bipolar I disorder received Abilify MyCite® tablets (aripiprazole-embedded IEM tablets).

This single-center trial was conducted in the United States. The overall time to participate in this study is up to approximately 17 days.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92845
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Cohort 1:

• In good general health or medically stable.
• Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
• The participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant.

Inclusion Criteria for Cohort 2:

• In good general health or medically stable.
• Has confirmed diagnosis of schizophrenia, major depressive disorder, or bipolar I disorder per Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and currently prescribed and taking aripiprazole.
• Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
• Participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant

Exclusion Criteria for Cohort 1 and 2:

• Any medical condition, treatment, or symptoms that, in the judgment of the trial clinician, could place the participant at more than the minimal risk from involvement in the testing.
• Hospitalization, emergency room visit, surgery or new medical treatment within 30 days before testing begins or planned during testing.
• Difficulty with or inability to swallow tablets.
• Active skin infection or active dermatitis, or history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis).
• The investigator will determine if any participant should be excluded from the trial based on history of, or current, alcohol abuse, drug abuse or use of illegal drugs (e.g., amphetamines or heroin).
• Allergy to adhesive bandages/tapes (e.g., Band-Aids®) or latex.
• Positive urine pregnancy test at screening visit (dipstick).
• Participant is taking any concomitant medication that places the participant at a greater risk for skin reactions or skin sensitivity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: D-Tect Patch; A D-Tect patch was applied by the clinical staff prior to each IEM tablet ingestion, and directly observed ingestions (DOIs), followed by ingestion of 15 placebo-embedded IEM tablets, 1 every 15 minutes in Cohort 1 on Day 1 and a single dose of Abilify MyCite® tablet in Cohort 2 on Day 1.

Drug: Placebo IEM tablet; Oral placebo-embedded IEM tablet.; Drug: Abilify MyCite®; Oral aripiprazole-embedded IEM tablet.; Other Names: OPC-14597 Digital; Device: D-Tect Patch; The D-Tect patch is a wearable sensor (WS) capable of detecting the ingestion of the IEM and measuring physiologic parameters. The WS automatically logs and stores the time when the IEM reaches the stomach and transmits the data to a smartphone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch	The PDA is calculated as the number of total positive detections by patch divided by the number of the total DOIs. PDA was estimated by Clopper-Pearson method.	At Day 1
Cohort 1 and 2: Patch Detection Latency Period	The patch detection latency period is defined as the time between the ingestion of the tablet and the detection of the tablet ingestion by the patch. Kaplan Meier estimation was used to measure the patch detection latency period.	At Day 1
Cohort 1 and 2: Ingestion Data Transfer Latency Period	The ingestion data transfer latency period is measured as the time between the detection of the tablet ingestion by the patch and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the ingestion data transfer latency period.	At Day 1
Cohort 1 and 2: Total Detection Latency Period	The total detection latency is measured as the total time between the ingestion of the tablet and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the total detection the latency period.	At Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation	TEAEs were defined as AEs that occurred on or after the participant wears any patch or takes any tablet from the study at test day, and the AEs that occurred before the participant wears any patch or takes any tablet and are worsening, serious, related, or resulted in death, discontinuation, or interruption of investigational product. A serious TEAE was defined as a TEAE that is fatal, life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, or requires inpatient hospitalization or prolongation of existing hospitalization.	From Day 1 up to follow-up (up to Day 10)

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): July 19, 2023

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: D-Tect patch
• Additional Relevant MeSH Terms: Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder; Schizophrenia; Mental Disorders; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 031-201-00521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No