Glyburide Healthy Volunteer Study

NCT01716338 | Completed Phase 1 DMC

• 1 other identifier: A-15112.b
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

glyburide; glybenclamide; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cognitive impact

  7 days

Study Arms (2)

Glyburide

ACTIVE COMPARATOR

1.5 mg (lowest dose) by mouth every day with breakfast for 7 days

Drug: Glyburide

Sugar Pill (Capsule)

PLACEBO COMPARATOR

Matching placebo capsule by mouth every day with breakfast for 7 days

Drug: Placebo

Interventions

Glyburide DRUG

Also known as: Micronase, Glybencamide

Glyburide

Placebo DRUG

Also known as: Sugar Pill (capsule)

Sugar Pill (Capsule)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• United States Department of Defense: collaborator
• University of Maryland: collaborator

Study Sites (1)

Washington University in St. Louis Clinical Research Unit (CRU)

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

Glyburide; Sugars; Capsules

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Carbohydrates; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Grant Bochicchio, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 29, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

US (1)