Glyburide Healthy Volunteer Study
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| First Received Date ICMJE | October 12, 2012 | ||||||||
| Last Updated Date | January 7, 2013 | ||||||||
| Start Date ICMJE | January 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of Participants with Adverse Events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01716338 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Cognitive impact [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Glyburide Healthy Volunteer Study | ||||||||
| Official Title ICMJE | Glyburide Healthy Volunteer Study | ||||||||
| 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. |
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| Detailed 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Healthy Volunteers | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 21 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01716338 | ||||||||
| Other Study ID Numbers ICMJE | A-15112.b | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Washington University School of Medicine | ||||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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