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NCT01132703 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Stroke and Traumatic Brain Injury, sponsored by Biogen.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target
1
Study location

NCT01132703: Completed Phase 1 study of Stroke and Traumatic Brain Injury, sponsored by Biogen.

NCT01132703 is a Phase 1 study of Stroke and Traumatic Brain Injury that has completed, run by Biogen. The registered enrollment target is 34 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01132703, a Phase 1 study of Stroke and Traumatic Brain Injury, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

An adverse event (AE) is defined as any untoward medical occurence such as a sign, symptom, and/or laboratory finding that is concurrent with the use of a drug in humans. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event

Interventions

  • DRUG Placebo
  • DRUG Glyburide for Injection

Study Locations (1)

Michigan

  • Jasper Clinic - Kalamazoo

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2010-01-07
Est. Completion 2010-05-07
Phase Phase 1
Biogen

334 total trials

What the finished NCT01132703 record still lists

NCT01132703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01132703 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT01132703 about?

NCT01132703 is a clinical study titled "Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers". 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 an...

What is the current status of trial NCT01132703?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-01-07. Estimated completion is 2010-05-07.

What conditions does trial NCT01132703 study?

This clinical trial studies the following conditions: Stroke, Traumatic Brain Injury.

What interventions are being tested in trial NCT01132703?

The interventions under investigation include: Placebo (DRUG), Glyburide for Injection (DRUG).

Who is sponsoring clinical trial NCT01132703?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01132703 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stroke

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01132703's enrollment target sits among peer trials

34 287th of 454 higher than 164 of 454 other Stroke trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01132703, the US trial registry maintained by the National Library of Medicine. NCT01132703 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.