Trial | NCT01132703  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    glyburide ...

  • Study Participants

    34
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.
This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.
Study Started
Jan 07
2010
Primary Completion
May 07
2010
Study Completion
May 07
2010
Last Update
Jun 21
2021

Drug Glyburide for Injection

Administered as specified in the Treatment Arm.

  • Other names: RP-1127, glibenclamide, glybenclamide

Drug Placebo

Administered as specified in the Treatment Arm.

Matching Placebo Placebo Comparator

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

Glyburide for Injection: Dose 1 Experimental

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

Glyburide for Injection: Dose 2 Experimental

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

Glyburide for Injection: Dose 3 Experimental

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

Criteria 

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.
No Results Posted