Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372210
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-03-29
Brief Title:
A Trial to Assess a Wearable Patchs Functioning to Detect Medication Ingestion
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to evaluate the positive detection accuracy PDA and detection latency measures of the 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None