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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Traumatic Brain Injury Stroke | Drug: Glyburide for Injection Drug: Placebo | Phase 1 |
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 |

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:
|
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:
|
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:
|
- 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
- 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 ]

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.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 |
Study Director: | Medical Director | Biogen |
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 |
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 |