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

Completed · Phase 1 · Has a placebo group

Conditions studied: Traumatic Brain Injury, Stroke

In brief

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.

Key facts

Study ID

NCT01132703

Run by

Biogen

People needed

34

Starts

2010-01-07

Expected to finish

2010-05-07

Last updated by the study team

2021-06-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Jasper Clinic — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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