The primary objective of this study is to assess the feasibility of enrolling, evaluating, and treating with glyburide for injection severe anterior circulation ischemic stroke participants, whether or not treated with standard of care intravenous (IV) recombinant tissue plasminogen activator (rtPA). Participants must be between 18-80 years of age, must have a baseline diffusion weighted image (DWI) lesion volume 82 -210 centimeters cubed (cm3), and time from symptom onset to start of study infusion must be ≤10 hour(hr). The secondary objectives are to assess the initial safety and tolerability, and pharmacokinetics (PK) /pharmacodynamics (PD) of glyburide in severe stroke participants, as well as to compare the clinical and magnetic resonance imaging (MRI) outcome data to benchmark data derived from published literature.
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Rate of Enrollment
Timeframe: Day 1
Percentage of Enrolled Participants to Screened Participants
Timeframe: Day 1
Percentage of Participants Completing 90-Day Follow-Up
Timeframe: Day 90
Percentage of Dose Reductions/ Dose Suspensions
Timeframe: Up to Day 3
Percentage of Participants With All Four MRI Assessments Per Protocol
Timeframe: Up to Day 3
Number of MRI Assessments Per Participant
Timeframe: Up to Day 3
Percentage of Participants Requiring One or More Hypoglycemia Treatments
Timeframe: Up to Day 4
Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol
Timeframe: Up to Day 4