A Phase 1 interventional study of Glyburide for Injection and Placebo in Traumatic Brain Injury and Stroke, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
The primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion. The secondary objectives are to assess the pharmacokinetics (PK) of glyburide and blood glucose and serum insulin pharmacodynamic (PD) responses to glyburide.
This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 34 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours.
Drug: Placebo
Glyburide is administered as a bolus followed by a infusion for 72 hours
Drug: Glyburide for Injection
Glyburide is administered as a bolus followed by a infusion for 72 hours
Drug: Glyburide for Injection
Glyburide is administered as a bolus followed by a infusion for 72 hours.
Drug: Glyburide for Injection
Administered as specified in the Treatment Arm.
Also known as: RP-1127, glibenclamide, glybenclamide
Administered as specified in the Treatment Arm.
Number of Participants with Adverse Events and Serious Adverse Events
An adverse event (AE) is defined as any untoward medical occurence such as a sign, symptom, and/or laboratory finding that is concurrent with the use of a drug in humans. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event
Time frame: Up to Day 28
Pharmacokinetic (PK) Parameter of Glyburide: Clearance (CL)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Volume of Distribution (Vz)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Elimination Rate Constant (λz)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Half-Life (t1/2)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Parameter of Glyburide: Predicted Steady-State Concentration (Css)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PK Paramater of Metabolites (M1 and M2): Maximum Plasma Concentrations (Cmax)
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
Pharmacodynamic (PD) Parameter of Glyburide: Change from Baseline in Blood Glucose
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
PD Parameter of Glyburide: Change from Baseline in Serum Insulin
Time frame: Day 1 (baseline) and at multiple time points up to Day 5
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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