Glyburide Healthy Volunteer Study

This study is a placebo controlled (2:1 drug vs. placebo), randomized clinical trial of 21
healthy, non-diabetic volunteers receiving daily doses of oral glyburide (1.5 mg) vs.
placebo while under careful medical monitoring in an inpatient General Clinical Research
Center (GCRC) at the University of Maryland Medical Center, for a duration of 7 days and
nights (24 hours per day). Interested subjects who call for more information about the study
will be scheduled for a screening visit. Subjects will participate first in an informed
consent process, and those wishing to take part will be asked to undergo a comprehensive
interview detailing their past medical history and formal physical examination (which
includes laboratory tests of the urine and blood). If a subject is deemed appropriate by the
team, he/she will be asked to perform an exercise test (treadmill for 30 minutes) and will
have an Electrocardiogram (ECG) completed to further determine eligibility. Individuals who
do not meet inclusion criteria based on screening activities will be notified immediately
that they are not eligible. Volunteers meeting all eligibility criteria will be scheduled
for the week long in-patient evaluation.

Each subject will undergo a battery of physical, cognitive, and laboratory tests in addition
to receiving oral glyburide or placebo each day for one week.

Inclusion Criteria:

1. Volunteers between the ages of 18 and 40.

2. Have a Body Mass Index (BMI) between 18-30.

3. Normal screening physical examination (non-pregnant as confirmed by serum Beta HcG,
non-diabetic as confirmed by normal Hgb A-1C, normal baseline ECG and vital signs,
laboratory values within normal limits. The lab tests include: complete blood count,
electrolytes, liver function tests, kidney function tests, uric acid, cholesterol,
iron, urinalysis, urine drug screen; all conducted within 2 weeks prior to
randomization.

4. Women of Childbearing Potential (WCP) demonstrate a willingness to use contraception
methods (other than birth control medications) to prevent pregnancy from time of
consent to 30 days past last dose. **Note, birth control medications MAY BE used
after completion of the inpatient hospital phase of the study (i.e. after discharge).

5. Unremarkable past medical history.

6. Ability to provide informed consent.

7. Ability to undergo physical exercise (determined through a treadmill exercise test to
ensure physical fitness of participants). Those who experience fatigue, dizziness or
chest pain during the screening exercise test on the treadmill will be excluded.

8. Ability to undergo neuropsychological test for attention, cognition, dexterity, etc.

9. Willing to remain in the in-patient setting for the duration of the study.

Exclusion Criteria:

1. Use of investigational drug within 4 weeks of study.

2. Using tobacco.

3. Acute illness or surgery within 4 weeks of study.

4. Allergic to sulfonylurea-related drugs.

5. Presence of pathological condition of any part of the body.

6. Any medication within 2 weeks of the study, including oral contraceptives.

7. Ingestion of alcohol or caffeine containing food or beverages within 48 hours of
start of study.

8. History of alcohol or drug abuse, cardiac arrhythmias, psychotropic agent use,
immunosuppressive condition (i.e. HIV, AIDS, Cancer) or hepatitis.

9. Donation of blood within 3 months or receiving blood products within 14 days.

10. Recent body tattoo or piercing.