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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

Tracking Information
First Submitted Date  ICMJE April 14, 2010
First Posted Date  ICMJE May 28, 2010
Last Update Posted Date June 21, 2021
Actual Study Start Date  ICMJE January 7, 2010
Actual Primary Completion Date May 7, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 28 Days ]
In particular, events of hypoglycemia and EKG changes will be studied
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Stroke
Intervention  ICMJE
  • Drug: Glyburide for Injection
    Administered as specified in the Treatment Arm.
    Other Names:
    • RP-1127
    • glibenclamide
    • glybenclamide
  • Drug: Placebo
    Administered as specified in the Treatment Arm.
Study Arms  ICMJE
  • Placebo Comparator: Matching Placebo
    Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours.
    Intervention: Drug: Placebo
  • Experimental: Glyburide for Injection: Dose 1
    Glyburide is administered as a bolus followed by a infusion for 72 hours
    Intervention: Drug: Glyburide for Injection
  • Experimental: Glyburide for Injection: Dose 2
    Glyburide is administered as a bolus followed by a infusion for 72 hours
    Intervention: Drug: Glyburide for Injection
  • Experimental: Glyburide for Injection: Dose 3
    Glyburide is administered as a bolus followed by a infusion for 72 hours.
    Intervention: Drug: Glyburide for Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2014)
34
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2010)
30
Actual Study Completion Date  ICMJE May 7, 2010
Actual Primary Completion Date May 7, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01132703
Other Study ID Numbers  ICMJE RPI 101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP