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

This study has been completed.
Information provided by (Responsible Party):
Remedy Pharmaceuticals, Inc. Identifier:
First received: April 14, 2010
Last updated: June 3, 2014
Last verified: May 2010
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 Intervention Phase
Traumatic Brain Injury
Drug: RP-1127 (Glyburide for injection)
Drug: Placebo (RP-1127 excipients, excluding active)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Remedy Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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

Enrollment: 34
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01132703

United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Remedy Pharmaceuticals, Inc.
  More Information

Responsible Party: Remedy Pharmaceuticals, Inc. Identifier: NCT01132703     History of Changes
Other Study ID Numbers: RPI 101
Study First Received: April 14, 2010
Last Updated: June 3, 2014

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 21, 2017