Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01132703 |
Recruitment Status :
Completed
First Posted : May 28, 2010
Last Update Posted : June 4, 2014
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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 |
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 |

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 |
- 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

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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:
- Between 18 and 55 years of age, inclusive.
- 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.

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
United States, Michigan | |
Jasper Clinic | |
Kalamazoo, Michigan, United States, 49007 |
Responsible Party: | Remedy Pharmaceuticals, Inc. |
ClinicalTrials.gov 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 |
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 |