Glyburide Healthy Volunteer Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01716338

Run by

Washington University School of Medicine

People needed

21

Starts

2013-01-01

Expected to finish

2014-08-01

Last updated by the study team

2014-09-16

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University in St. Louis Clinical Research Unit (CRU) — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.