Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

The primary objective of this clinical trial is to evaluate the acceptability, tolerability,
and efficacy of the ID-Cap system in a healthy population. The ID-Cap is an ingestible
medical device for detecting the presence of an ingested capsule inside the gastrointestinal
(GI) tract.

Participation in the study takes 3 visits over a period of approximately six weeks. The first
visit is a screening visit to determine if participants are eligible to participate. After
the initial assessment visit, participants will be randomized to one of two groups. Group 1
will have adherence measured by self-report, pill count, and urine riboflavin levels. This
group will not receive capsules containing ingestible sensors, but will receive their
medication in a bottle capped with a MEMS Track Cap, which records when the medication bottle
is opened and closed. Group 2 will receive capsules containing an ingestible sensor and will
have adherence measured by self-report, pill count, urine riboflavin levels as needed, and
data collected by an ID-Cap reader. Participants randomized to this group will also receive
reminder calls and/or text messages to ingest the study medication if a signal is not sent
from the ID-Cap reader to the study team within one hour of the scheduled medication
administration time. They will also be using biometric identification technology to confirm
subject identity, specifically electrocardiogram (ECG).

After the initial screening visit, participants will be required to attend two clinic visits
during the six-week study, a randomization visit and a one-week follow-up visit approximately
one week after last medication dose.

Inclusion Criteria:

- Must be between the ages of 18 and 65 years

- If female and of childbearing potential, must agree to use acceptable methods of birth
control for the duration of the trial

- Must consent to random assignment, and be willing to commit to medication ingestion

- Must be able to read and provide informed consent

- Must function at an intellectual level sufficient to allow accurate completion of
assessments

- Must have a Body Mass Index (BMI) below 35

Exclusion Criteria:

- Women who are pregnant, nursing, or plan to become pregnant during the course of the
study

- Must not have evidence of a significant medical condition which may affect capsule
passage through the gastrointestinal tract (including, but not limited to, Crohn's
disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation
enteritis)

- Must not have a current major psychiatric disorder as these may interfere with
assessment measures

- Must not be currently dependent on other substances, with the exception of nicotine or
caffeine, within the past 60 days

- Hypersensitivity to riboflavin or any capsule component;

- Individuals with embedded electronic devices

- Patients who, in the investigator's opinion, would be unable to comply with study
procedures or assessments, or would be unacceptable study candidates (e.g., poses
threat to staff)