Glyburide Healthy Volunteer Study

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Glyburide is a medication that has been safely used for several decades to treat non-insulin dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and cognitively. The investigators are hopeful that the results of this study will provide the necessary foundation to evaluate this medication's use on a larger scale to determine the feasibility of using glyburide in soldiers either prophylactically or for the treatment of brain injury.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: United States Department of Defense; University of Maryland; University of Maryland, College Park
• Treatments: Glyburide

Criteria

Inclusion Criteria:

• Volunteers between the ages of 18 and 40.

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

• 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 are conducted within 2 weeks prior to randomization).

• 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).

• Unremarkable past medical history.

• Ability to provide informed consent.

• 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.

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

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

Exclusion Criteria:

• Use of investigational drug within 4 weeks of study.

• Using tobacco.

• Acute illness or surgery within 4 weeks of study.

• Allergic to sulfonylurea-related drugs.

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

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

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

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

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

• Recent body tattoo or piercing.