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

NCT ID: NCT01132703

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-07
• Study Completion Date: 2010-05-07

Brief Summary

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.

Detailed Description

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

Conditions

Traumatic Brain Injury; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Matching Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered as specified in the Treatment Arm.

Glyburide for Injection: Dose 1

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

Group Type: EXPERIMENTAL

Glyburide for Injection

Intervention Type: DRUG

Administered as specified in the Treatment Arm.

Glyburide for Injection: Dose 2

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

Group Type: EXPERIMENTAL

Glyburide for Injection

Intervention Type: DRUG

Administered as specified in the Treatment Arm.

Glyburide for Injection: Dose 3

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

Group Type: EXPERIMENTAL

Glyburide for Injection

Intervention Type: DRUG

Administered as specified in the Treatment Arm.

Interventions

Glyburide for Injection

Administered as specified in the Treatment Arm.

Intervention Type: DRUG

Placebo

Administered as specified in the Treatment Arm.

Intervention Type: DRUG

Other Intervention Names

RP-1127; glibenclamide; glybenclamide

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Jasper Clinic

Kalamazoo, Michigan, United States

Countries

United States

Other Identifiers

RPI 101

Identifier Type: -

Identifier Source: org_study_id