Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)

Completed · Phase 4 · Has a placebo group

Conditions studied: Device Latency

In brief

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.

Key facts

Study ID

NCT02404532

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

30

Starts

2015-02-01

Expected to finish

2015-03-01

Last updated by the study team

2018-08-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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