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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matching Placebo | Placebo Comparator | Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours. |
|
| Glyburide for Injection: Dose 1 | Experimental | Glyburide is administered as a bolus followed by a infusion for 72 hours |
|
| Glyburide for Injection: Dose 2 | Experimental | Glyburide is administered as a bolus followed by a infusion for 72 hours |
|
| Glyburide for Injection: Dose 3 | Experimental | Glyburide is administered as a bolus followed by a infusion for 72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glyburide for Injection | Drug | Administered as specified in the Treatment Arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter of Glyburide: Clearance (CL) | Day 1 (baseline) and at multiple time points up to Day 5 | |
| PK Parameter of Glyburide: Volume of Distribution (Vz) | Day 1 (baseline) and at multiple time points up to Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Clinic | Kalamazoo | Michigan | 49007 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005905 | Glyburide |
| D007267 | Injections |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Administered as specified in the Treatment Arm. |
|
| PK Parameter of Glyburide: Elimination Rate Constant (λz) | Day 1 (baseline) and at multiple time points up to Day 5 |
| PK Parameter of Glyburide: Half-Life (t1/2) | Day 1 (baseline) and at multiple time points up to Day 5 |
| PK Parameter of Glyburide: Predicted Steady-State Concentration (Css) | Day 1 (baseline) and at multiple time points up to Day 5 |
| PK Paramater of Metabolites (M1 and M2): Maximum Plasma Concentrations (Cmax) | Day 1 (baseline) and at multiple time points up to Day 5 |
| Pharmacodynamic (PD) Parameter of Glyburide: Change from Baseline in Blood Glucose | Day 1 (baseline) and at multiple time points up to Day 5 |
| PD Parameter of Glyburide: Change from Baseline in Serum Insulin | Day 1 (baseline) and at multiple time points up to Day 5 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |