NCT01132703

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Glyburide for Injection	Administered as specified in the Treatment Arm.
DRUG	Placebo	Administered as specified in the Treatment Arm.

Timeline

• Start date: 2010-01-07
• Primary completion: 2010-05-07
• Completion: 2010-05-07
• First posted: 2010-05-28
• Last updated: 2021-06-21

Locations

1 site across 1 country: United States