Glyburide Healthy Volunteer Study

Healthy Volunteers Clinical Trial

Official title:

Glyburide Healthy Volunteer Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716338
• Other study ID #: A-15112.b
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2012
• Last updated: September 15, 2014
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Department of Defense
• Study type: Interventional

Clinical Trial 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.

Description:

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 Clinical Research Unit (CRU)within the Center for Applied Research Sciences (CARS) at the Washington University in St. Louis 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.

Other known NCT identifiers

• NCT01157637

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Glyburide

• Placebo

Locations

Country	Name	City	State
United States	Washington University in St. Louis Clinical Research Unit (CRU)	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	United States Department of Defense, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	The primary objective of this study is to evaluate the safety of glyburide in healthy, non-diabetic volunteers while simulating strenuous activity to observe for any adverse events (i.e. hypoglycemia, dizziness, confusion, etc.). Neuropsychological testing, physical exams, vital signs, ECGs, cognitive assessments, and laboratory values (including serum glucose levels collected 4 x's per day and as needed) will be conducted throughout the 7 day in-patient study to assess for any adverse/serious adverse events.	7 days	Yes
Secondary	Cognitive impact	Determine the impact after 7 days of glyburide 1.5mg daily (with breakfast) in healthy volunteers who are able to participate in scheduled strenuous activities and adhere to a structured meal plan on cognitive performance using a computer program to test cognition before study drug administration and at the end of the study in addition to daily physical examinations which include mini mental status exams.	7 days	Yes