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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. Identifier: NCT01132703
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : June 4, 2014
Information provided by (Responsible Party):
Remedy Pharmaceuticals, Inc.

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of RP-1127 (glyburide for injection), administered as a bolus dose followed by a 3 day continuous infusion. The secondary objectives are to assess the pharmacokinetics of RP-1127 and blood glucose and serum insulin PD responses to RP-1127.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Stroke Drug: RP-1127 (Glyburide for injection) Drug: Placebo (RP-1127 excipients, excluding active) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel 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
Study Start Date : February 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide

Arm Intervention/treatment
Experimental: RP-1127 (Glyburide for Injection) Drug: RP-1127 (Glyburide for injection)
RP-1127 is administered as a bolus followed by continuous infusion for 72 hours

Placebo Comparator: Placebo
Placebo (RP-1127 excipients without active)
Drug: Placebo (RP-1127 excipients, excluding active)
RP-1127 excipients, excluding active

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Between 18 and 55 years of age, inclusive.
  2. A healthy male or a healthy nonpregnant, nonlactating female.
  3. Capable of understanding and complying with the protocol and has signed the informed consent form before the Screening procedures begin.
  4. Have a body mass index of between 18.0 and 30.0 kg/m², inclusive.
  5. A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening laboratory studies and urinalysis.
  6. 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 identifier (NCT number): NCT01132703

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United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Remedy Pharmaceuticals, Inc.
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Responsible Party: Remedy Pharmaceuticals, Inc. Identifier: NCT01132703    
Other Study ID Numbers: RPI 101
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: May 2010
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Hypoglycemic Agents
Physiological Effects of Drugs