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

Completed

Phase 1 Results N/A

Trial Description

The primary objective of this study is to evaluate the safety and tolerability of RP-1127 (glyburide for injection), administered as a bolus dose followed by a 3 day continuous infusion. The secondary objectives are to assess the pharmacokinetics of RP-1127 and blood glucose and serum insulin PD responses to RP-1127.

Conditions

Interventions

  • RP-1127 (Glyburide for injection) Drug
    Other Names: glibenclamide; glybenclamide
    Intervention Desc: RP-1127 is administered as a bolus followed by continuous infusion for 72 hours
    ARM 1: Kind: Experimental
    Label: RP-1127 (Glyburide for Injection)
  • Placebo (RP-1127 excipients, excluding active) Drug
    Intervention Desc: RP-1127 excipients, excluding active
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo (RP-1127 excipients without active)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 28 Days Yes

Sponsors