Back to resultsSafety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
Primary Purpose
Traumatic Brain Injury, Stroke
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glyburide for Injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- A healthy male or a healthy nonpregnant, nonlactating female.
- Capable of understanding and complying with the protocol and has signed the informed consent form before the Screening procedures begin.
- Have a body mass index of between 18.0 and 30.0 kg/m², inclusive.
- A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening laboratory studies and urinalysis.
- A negative urine or saliva test for selected substances of abuse and cotinine.
Exclusion Criteria:
- Clinically significant history of hypoglycemia as assessed by the investigator.
- History of seizure disorder, even if currently not receiving anticonvulsant medications.
- History of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic medications, or other sulfa drugs.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency as determined by G6PD enzyme testing at screening.
- Be an active smoker or user of other forms of tobacco. Former smokers or tobacco users must have refrained from smoking or using other forms of tobacco for at least 6 months prior to dosing on Study Day 1.
- A history or clinical manifestations of significant metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders (a history of mild depression, currently not receiving therapy, is acceptable).
- Use any prescription medication within 14 days prior to randomization, or nonprescription drugs within 7 days. Exceptions may be made by the medical monitor on a case-by-case basis.
- Received another investigational drug within 30 days prior to randomization.
- A positive hepatitis virus test (Hepatitis B virus surface antigen or hepatitis C virus antibody) or a positive human immunodeficiency virus (HIV) antibody test at screening. If the HIV test is positive, the subject will be informed privately and referred for additional counseling.
Sites / Locations
- Jasper Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Matching Placebo
Glyburide for Injection: Dose 1
Glyburide for Injection: Dose 2
Glyburide for Injection: Dose 3
Arm Description
Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours.
Glyburide is administered as a bolus followed by a infusion for 72 hours
Glyburide is administered as a bolus followed by a infusion for 72 hours
Glyburide is administered as a bolus followed by a infusion for 72 hours.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharmacokinetic (PK) Parameter of Glyburide: Clearance (CL)
PK Parameter of Glyburide: Volume of Distribution (Vz)
PK Parameter of Glyburide: Elimination Rate Constant (λz)
PK Parameter of Glyburide: Half-Life (t1/2)
PK Parameter of Glyburide: Predicted Steady-State Concentration (Css)
PK Paramater of Metabolites (M1 and M2): Maximum Plasma Concentrations (Cmax)
Pharmacodynamic (PD) Parameter of Glyburide: Change from Baseline in Blood Glucose
PD Parameter of Glyburide: Change from Baseline in Serum Insulin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01132703
Brief Title
Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
Official Title
A Phase I Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of RP-1127 (Glyburide for Injection) in Healthy Male and Female Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2010 (Actual)
Primary Completion Date
May 7, 2010 (Actual)
Study Completion Date
May 7, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours.
Arm Title
Glyburide for Injection: Dose 1
Arm Type
Experimental
Arm Description
Glyburide is administered as a bolus followed by a infusion for 72 hours
Arm Title
Glyburide for Injection: Dose 2
Arm Type
Experimental
Arm Description
Glyburide is administered as a bolus followed by a infusion for 72 hours
Arm Title
Glyburide for Injection: Dose 3
Arm Type
Experimental
Arm Description
Glyburide is administered as a bolus followed by a infusion for 72 hours.
Intervention Type
Drug
Intervention Name(s)
Glyburide for Injection
Other Intervention Name(s)
RP-1127, glibenclamide, glybenclamide
Intervention Description
Administered as specified in the Treatment Arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the Treatment Arm.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events and Serious Adverse Events
Description
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
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter of Glyburide: Clearance (CL)
Time Frame
Day 1 (baseline) and at multiple time points up to Day 5
Title
PK Parameter of Glyburide: Volume of Distribution (Vz)
Time Frame
Day 1 (baseline) and at multiple time points up to Day 5
Title
PK Parameter of Glyburide: Elimination Rate Constant (λz)
Time Frame
Day 1 (baseline) and at multiple time points up to Day 5
Title
PK Parameter of Glyburide: Half-Life (t1/2)
Time Frame
Day 1 (baseline) and at multiple time points up to Day 5
Title
PK Parameter of Glyburide: Predicted Steady-State Concentration (Css)
Time Frame
Day 1 (baseline) and at multiple time points up to Day 5
Title
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
Title
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
Title
PD Parameter of Glyburide: Change from Baseline in Serum Insulin
Time Frame
Day 1 (baseline) and at multiple time points up to Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A healthy male or a healthy nonpregnant, nonlactating female.
Capable of understanding and complying with the protocol and has signed the informed consent form before the Screening procedures begin.
Have a body mass index of between 18.0 and 30.0 kg/m², inclusive.
A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening laboratory studies and urinalysis.
A negative urine or saliva test for selected substances of abuse and cotinine.
Exclusion Criteria:
Clinically significant history of hypoglycemia as assessed by the investigator.
History of seizure disorder, even if currently not receiving anticonvulsant medications.
History of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic medications, or other sulfa drugs.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency as determined by G6PD enzyme testing at screening.
Be an active smoker or user of other forms of tobacco. Former smokers or tobacco users must have refrained from smoking or using other forms of tobacco for at least 6 months prior to dosing on Study Day 1.
A history or clinical manifestations of significant metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders (a history of mild depression, currently not receiving therapy, is acceptable).
Use any prescription medication within 14 days prior to randomization, or nonprescription drugs within 7 days. Exceptions may be made by the medical monitor on a case-by-case basis.
Received another investigational drug within 30 days prior to randomization.
A positive hepatitis virus test (Hepatitis B virus surface antigen or hepatitis C virus antibody) or a positive human immunodeficiency virus (HIV) antibody test at screening. If the HIV test is positive, the subject will be informed privately and referred for additional counseling.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Jasper Clinic
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
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