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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 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.

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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.

Conditions Studied

Stroke Traumatic Brain Injury

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

Sponsor

Biogen

334 total trials

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What the Registry Record Tells You About NCT01132703

The ClinicalTrials.gov registry entry for NCT01132703 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.