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

Biogen

Status and phase: Completed; Phase 1

Conditions: Traumatic Brain Injury; Stroke

Treatments: Drug: Glyburide for Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01132703

RPI 101

Details and patient eligibility

About

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.

Full description

This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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34 participants in 4 patient groups, including a placebo group

Matching Placebo

Placebo Comparator group

Description:

Matching placebo (glyburide excipients without active) is administered as a bolus followed by continuous infusion for 72 hours.

Treatment:

Drug: Placebo

Glyburide for Injection: Dose 1

Experimental group

Description:

Glyburide is administered as a bolus followed by a infusion for 72 hours

Treatment:

Drug: Glyburide for Injection

Glyburide for Injection: Dose 2

Experimental group

Description:

Glyburide is administered as a bolus followed by a infusion for 72 hours

Treatment:

Drug: Glyburide for Injection

Glyburide for Injection: Dose 3

Experimental group

Description:

Glyburide is administered as a bolus followed by a infusion for 72 hours.

Treatment:

Drug: Glyburide for Injection