Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01132703
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Stroke Drug: Glyburide for Injection Drug: Placebo Phase 1

Detailed Description:
This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 7, 2010
Actual Primary Completion Date : May 7, 2010
Actual Study Completion Date : May 7, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide

Arm Intervention/treatment
Placebo Comparator: Matching Placebo
Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours.
Drug: Placebo
Administered as specified in the Treatment Arm.

Experimental: Glyburide for Injection: Dose 1
Glyburide is administered as a bolus followed by a infusion for 72 hours
Drug: Glyburide for Injection
Administered as specified in the Treatment Arm.
Other Names:
  • RP-1127
  • glibenclamide
  • glybenclamide

Experimental: Glyburide for Injection: Dose 2
Glyburide is administered as a bolus followed by a infusion for 72 hours
Drug: Glyburide for Injection
Administered as specified in the Treatment Arm.
Other Names:
  • RP-1127
  • glibenclamide
  • glybenclamide

Experimental: Glyburide for Injection: Dose 3
Glyburide is administered as a bolus followed by a infusion for 72 hours.
Drug: Glyburide for Injection
Administered as specified in the Treatment Arm.
Other Names:
  • RP-1127
  • glibenclamide
  • glybenclamide




Primary Outcome Measures :
  1. Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to Day 28 ]
    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 :
  1. Pharmacokinetic (PK) Parameter of Glyburide: Clearance (CL) [ Time Frame: Day 1 (baseline) and at multiple time points up to Day 5 ]
  2. PK Parameter of Glyburide: Volume of Distribution (Vz) [ Time Frame: Day 1 (baseline) and at multiple time points up to Day 5 ]
  3. PK Parameter of Glyburide: Elimination Rate Constant (λz) [ Time Frame: Day 1 (baseline) and at multiple time points up to Day 5 ]
  4. PK Parameter of Glyburide: Half-Life (t1/2) [ Time Frame: Day 1 (baseline) and at multiple time points up to Day 5 ]
  5. PK Parameter of Glyburide: Predicted Steady-State Concentration (Css) [ Time Frame: Day 1 (baseline) and at multiple time points up to Day 5 ]
  6. 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 ]
  7. 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 ]
  8. PD Parameter of Glyburide: Change from Baseline in Serum Insulin [ Time Frame: Day 1 (baseline) and at multiple time points up to Day 5 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A healthy male or a healthy nonpregnant, nonlactating female.
  2. Capable of understanding and complying with the protocol and has signed the informed consent form before the Screening procedures begin.
  3. Have a body mass index of between 18.0 and 30.0 kg/m², inclusive.
  4. A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening laboratory studies and urinalysis.
  5. A negative urine or saliva test for selected substances of abuse and cotinine.

Exclusion Criteria:

  1. Clinically significant history of hypoglycemia as assessed by the investigator.
  2. History of seizure disorder, even if currently not receiving anticonvulsant medications.
  3. History of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic medications, or other sulfa drugs.
  4. Glucose-6-phosphate dehydrogenase (G6PD) deficiency as determined by G6PD enzyme testing at screening.
  5. 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.
  6. 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).
  7. 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.
  8. Received another investigational drug within 30 days prior to randomization.
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132703


Locations
Layout table for location information
United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01132703    
Other Study ID Numbers: RPI 101
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs